CARESCAPE Monitor B850…

Date

Feb. 12, 2014

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel.

Reason

There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communicatio

Distribution pattern

Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Australia, Austria, Azerbaijan, Bahrain, Belgium, BRAZIL, Canada, CHILE, COSTA RICA, Cyprus, Czech Republic, Denmark, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, GUAM, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Republic of, Kuwait, Lithuania, Malaysia, Malta, Mexico, NEPAL, Netherlands, New Zealand, Norway, Pakistan, PANAMA, PARAGUAY, PERU, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, United Republic of, Turkey, United Arab Emirates, United Kingdom, URUGUAY.

Quantity

12, 945 units (6,239 US, 6,706 OUS)

Codes and lots

serial numbers: SEG09270517HX, SEG09270549HX, SEG09270551HX, SEG09270553HX, SEG09270554HX, SEG09270557HX, SEG09270559HX, SEG09270561HX, SEG09270562HX, SEG09270563HX, SEG09270564HX, SEG09270565HX, SEG09270566HX, SEG09270567HX, SEG09270568HX, SEG09270569HX, SEG09270583HX, SEG09270584HX, SEG09270585HX, SEG09270587HX, SEG09270588HX, SEG09270589HX, SEG09270591HX, SEG09270592HX, SEG09280596HX, SEG09280597HX, SEG09280598HX, SEG09280599HX, SEG09280600HX, SEG09280601HX, SEG09280602HX, SEG09280603HX, SEG09280604HX, SEG09280605HX, SEG09280606HX, SEG09280607HX, SEG09280608HX, SEG09280609HX, SEG09280610HX, SEG09280611HX, SEG09280612HX, SEG09280613HX, SEG09280614HX, SEG09280615HX, SEG09280616HX, SEG09280617HX, SEG09280618HX, SEG09280619HX, SEG09280620HX, SEG09280621HX, SEG09280622HX, SEG09280623HX, SEG09280624HX, SEG09280625HX, SEG09310656HX, SEG09310657HX, SEG09310658HX, SEG09310659HX, SEG09310660HX, SEG09310661HX, SEG09310662HX, SEG09310663HX, SEG09310664HX, SEG09310665HX, SEG09310666HX, SEG09310667HX, SEG09310668HX, SEG09310669HX, SEG09310670HX, SEG09310671HX, SEG09310672HX, SEG09310673HX, SEG09310674HX, SEG09310675HX, SEG09310696HX, SEG09310697HX, SEG09310698HX, SEG09310699HX, SEG09310700HX, SEG09310701HX, SEG09310702HX, SEG09310703HX, SEG09310704HX, SEG09310705HX, SEG09310706HX, SEG09310707HX, SEG09310708HX, SEG09310709HX, SEG09310710HX, SEG09310711HX, SEG09310712HX, SEG09310713HX, SEG09310714HX, SEG09310715HX, SEG09310716HX, SEG09310717HX, SEG09310718HX, SEG09310719HX, SEG09310720HX, SEG09310721HX, SEG09310722HX, SEG09310723HX, SEG09310724HX, SEG09310725HX, SEG09310726HX, SEG09310727HX, SEG09310728HX, SEG09310729HX, SEG09310730HX, SEG09310731HX, SEG09310732HX, SEG09310733HX, SEG09310734HX, SEG09310735HX, SEG09310736HX, SEG09310737HX, SEG09310738HX, SEG09310739HX, SEG09310740HX, SEG09310741HX, SEG09310742HX, SEG09310743HX, SEG09310744HX, SEG09310745HX, SEG09320797HX, SEG09320798HX, SEG09320799HX, SEG09320800HX, SEG09320801HX, SEG09320802HX, SEG09320803HX, SEG09320804HX, SEG09320805HX, SEG09320806HX, SEG09320807HX, SEG09320808HX, SEG09320809HX, SEG09320810HX, SEG09320811HX, SEG09320812HX, SEG09320813HX, SEG09320814HX, SEG09320815HX, SEG09320816HX, SEG09320817HX, SEG09320818HX, SEG09320819HX, SEG09320820HX, SEG09320821HX, SEG09320822HX, SEG09320823HX, SEG09320824HX, SEG09320825HX, SEG09320826HX, SEG09320827HX, SEG09320828HX, SEG09320829HX, SEG09320830HX, SEG09320831HX, SEG09320832HX, SEG09320833HX, SEG09320834HX, SEG09320835HX, SEG09320836HX, SEG09320837HX, SEG09320838HX, SEG09320839HX, SEG09320840HX, SEG09320841HX, SEG09320842HX, SEG09320843HX, SEG09320844HX, SEG09320845HX, SEG09320846HX, SEG09320847HX, SEG09320848HX, SEG09320849HX, SEG09320850HX, SEG09320851HX, SEG09320852HX, SEG09320853HX, SEG09320854HX, SEG09320855HX, SEG09320856HX, SEG09320857HX, SEG09320858HX, SEG09320859HX, SEG09320860HX, SEG09320861HX, SEG09320862HX, SEG09320863HX, SEG09320864HX, SEG09320865HX, SEG09320866HX, SEG09320867HX, SEG09320868HX, SEG09320869HX, SEG09320870HX, SEG09320871HX, SEG09320872HX, SEG09320873HX, SEG09320874HX, SEG09320875HX, SEG09320876HX, SEG09320877HX, SEG09320878HX, SEG09320879HX, SEG09320880HX, SEG09320881HX, SEG09320882HX, SEG09320883HX, SEG09320884HX, SEG09320885HX, SEG09320886HX, SEG09320887HX, SEG09320888HX, SEG09320889HX, SEG09320890HX, SEG09320891HX, SEG09320892HX, SEG09320893HX, SEG09320894HX, SEG09320895HX, SEG09320896HX, SEG09360898HX, SEG09360899HX, SEG09360900HX, SEG09360901HX, SEG09360902HX, SEG09360903HX, SEG09360904HX, SEG09360905HX, SEG09360906HX, SEG09360907HX, SEG09360908HX, SEG09360909HX, SEG09360910HX, SEG09360911HX, SEG09360912HX, SEG09360913HX, SEG09360914HX, SEG09360915HX, SEG09360916HX, SEG09360917HX, SEG09360918HX, SEG09360919HX, SEG09360920HX, SEG09360921HX, SEG09360922HX, SEG09360923HX, SEG09360924HX, SEG09360925HX, SEG09360926HX, SEG09360927HX, SEG09360928HX, SEG09360929HX, SEG09360930HX, SEG09360931HX, SEG09360932HX, SEG09360933HX, SEG09360934HX, SEG09360935HX, SEG09360936HX, SEG09360937HX, SEG09360938HX, SEG09360939HX, SEG09360940HX, SEG09360941HX, SEG09360942HX, SEG09360943HX, SEG09360944HX, SEG09360945HX, SEG09360946HX, SEG09360947HX, SEG09370948HX, SEG09370949HX, SEG09370950HX, SEG09370951HX, SEG09370952HX, SEG09370953HX, SEG09370954HX, SEG09370955HX, SEG09370956HX, SEG09370957HX, SEG09370958HX, SEG09370959HX, SEG09370960HX, SEG09370961HX, SEG09370962HX, SEG09370963HX, SEG09370964HX, SEG09370965HX, SEG09370966HX, SEG09370967HX, SEG09370968HX, SEG09370969HX, SEG09370970HX, SEG09370971HX, SEG09370972HX, SEG09370973HX, SEG09370974HX, SEG09370975HX, SEG09370976HX, SEG09370977HX, SEG09370978HX, SEG09370979HX, SEG09370980HX, SEG09370981HX, SEG09370982HX, SEG09370983HX, SEG09370984HX, SEG09370985HX, SEG09370986HX, SEG09370987HX, SEG09370988HX, SEG09370989HX, SEG09370990HX, SEG09370991HX, SEG09370992HX, SEG09370993HX, SEG09370994HX, SEG09370995HX, SEG09370996HX, SEG09370997HX, SEG09370998HX, SEG09370999HX, SEG09371000HX, SEG09371001HX, SEG09371002HX, SEG09371003HX, SEG09371004HX, SEG09371005HX, SEG09371006HX, SEG09371007HX, SEG09371008HX, SEG09371009HX, SEG09371010HX, SEG09371011HX, SEG09371012HX, SEG09371013HX, SEG09371014HX, SEG09371015HX, SEG09371016HX, SEG09371017HX, SEG09371018HX, SEG09371019HX, SEG09371020HX, SEG09371021HX, SEG09371022HX, SEG09371023HX, SEG09371024HX, SEG09371025HX, SEG09371026HX, SEG09371027HX, SEG09371028HX, SEG09371029HX, SEG09371030HX, SEG09371031HX, SEG09371032HX, SEG09371033HX, SEG09371034HX, SEG09371035HX, SEG09371036HX, SEG09371037HX, SEG09371038HX, SEG09371039HX, SEG09371040HX, SEG09371041HX, SEG09371042HX, SEG09371043HX, SEG09371044HX, SEG09371045HX, SEG09371046HX, SEG09371047HX, SEG09371048HX, SEG09371049HX, SEG09371050HX, SEG09371051HX, SEG09371052HX, SEG09371053HX, SEG09371054HX, SEG09371055HX, SEG09371056HX, SEG09371057HX, SEG09371058HX, SEG09371059HX, SEG09371060HX, SEG09371061HX, SEG09371062HX, SEG09371063HX, SEG09371064HX, SEG09371065HX, SEG09371066HX, SEG09371067HX, SEG09381068HX, SEG09381069HX, SEG09381070HX, SEG09381071HX, SEG09381072HX, SEG09381073HX, SEG09381074HX, SEG09381075HX, SEG09381076HX, SEG09381077HX, SEG09381078HX, SEG09381079HX, SEG09381080HX, SEG09381081HX, SEG09381082HX, SEG09381083HX, SEG09381084HX, SEG09381085HX, SEG09381086HX, SEG09381087HX, SEG09381088HX, SEG09381089HX, SEG09381090HX, SEG09381091HX, SEG09381092HX, SEG09381093HX, SEG09381094HX, SEG09381095HX, SEG09381096HX, SEG09381097HX, SEG09381098HX, SEG09381099HX, SEG09381100HX, SEG09381101HX, SEG09381102HX, SEG09381103HX, SEG09381104HX, SEG09381105HX, SEG09381106HX, SEG09381107HX, SEG09381108HX, SEG09381109HX, SEG09381110HX, SEG09381111HX, SEG09381112HX, SEG09381113HX, SEG09381114HX, SEG09381115HX, SEG09381116HX, SEG09381117HX, SEG09381118HX, SEG09381119HX, SEG09381120HX, SEG09381121HX, SEG09381122HX, SEG09381123HX, SEG09381124HX, SEG09381125HX, SEG09381126HX, SEG09381127HX, SEG09381128HX, SEG09381129HX, SEG09381130HX, SEG09381131HX, SEG09381132HX, SEG09381133HX, SEG09381134HX, SEG09381135HX, SEG09381136HX, SEG09381137HX, SEG09381138HX, SEG09381139HX, SEG09381140HX, SEG09381141HX, SEG09381142HX, SEG09381143HX, SEG09381144HX, SEG09381145HX, SEG09381146HX, SEG09381147HX, SEG09381148HX, SEG09381149HX, SEG09381150HX, SEG09381151HX, SEG09381152HX, SEG09381153HX, SEG09381154HX, SEG09381155HX, SEG09381156HX, SEG09381157HX, SEG09381158HX, SEG09381159HX, SEG09381160HX, SEG09381161HX, SEG09381162HX, SEG09381163HX, SEG09381164HX, SEG09381165HX, SEG09381166HX, SEG09381167HX, SEG09411368HX, SEG09411369HX, SEG09411370HX, SEG09411371HX, SEG09411372HX, SEG09411373HX, SEG09411374HX, SEG09411375HX, SEG09411376HX, SEG09411377HX, SEG09411378HX, SEG09411379HX, SEG09411380HX, SEG09411381HX, SEG09411382HX, SEG09411383HX, SEG09411384HX, SEG09411385HX, SEG09411386HX, SEG09411387HX, SEG09411388HX, SEG09411389HX, SEG09411390HX, SEG09411391HX, SEG09411393HX, SEG09411394HX, SEG09411395HX, SEG09411396HX, SEG09411397HX, SEG09411398HX, SEG09411399HX, SEG09411400HX, SEG09411401HX, SEG09411402HX, SEG09411403HX, SEG09411404HX, SEG09411405HX, SEG09411406HX, SEG09411407HX, SEG09411408HX, SEG09411409HX, SEG09411410HX, SEG09411411HX, SEG09411412HX, SEG09411413HX, SEG09411414HX, SEG09411415HX, SEG09411416HX, SEG09411417HX, SEG09411418HX, SEG09411419HX, SEG09411420HX, SEG09411421HX, SEG09411422HX, SEG09411423HX, SEG09411424HX, SEG09411425HX, SEG09411426HX, SEG09411427HX, SEG09411428HX, SEG09411429HX, SEG09411430HX, SEG09411431HX, SEG09411432HX, SEG09411433HX, SEG09411434HX, SEG09411435HX, SEG09411436HX, SEG09411437HX, SEG09411438HX, SEG09411439HX, SEG09411440HX, SEG09411441HX, SEG09411442HX, SEG09411443HX, SEG09411444HX, SEG09411445HX, SEG09411446HX, SEG09411447HX, SEG09411448HX, SEG09411449HX, SEG09411450HX, SEG09411451HX, SEG09411452HX, SEG09411453HX, SEG09411454HX, SEG09411455HX, SEG09411456HX, SEG09411457HX, SEG09411458HX, SEG09411459HX, SEG09411460HX, SEG09411461HX, SEG09411462HX, SEG09411463HX, SEG09411464HX, SEG09411465HX, SEG09411466HX, SEG09411467HX, SEG09411468HX, SEG09411469HX, SEG09411470HX, SEG09411471HX, SEG09411472HX, SEG09411473HX, SEG09411474HX, SEG09411475HX, SEG09411476HX, SEG09411477HX, SEG09411478HX, SEG09411479HX, SEG09411480HX, SEG09411481HX, SEG09411482HX, SEG09411483HX, SEG09411484HX, SEG09411485HX, SEG09411486HX, SEG09411487HX, SEG09411488HX, SEG09411489HX, SEG09411490HX, SEG09411491HX, SEG09411492HX, SEG09411493HX, SEG09411494HX, SEG09411495HX, SEG09411496HX, SEG09411497HX, SEG09411498HX, SEG09411499HX, SEG09411500HX, SEG09411501HX, SEG09411502HX, SEG09411503HX, SEG09411504HX, SEG09411505HX, SEG09411506HX, SEG09411507HX, SEG09411508HX, SEG09411509HX, SEG09411510HX, SEG09411511HX, SEG09411512HX, SEG09411513HX, SEG09411514HX, SEG09411515HX, SEG09411516HX, SEG09411517HX, SEG09411518HX, SEG09411519HX, SEG09411520HX, SEG09411521HX, SEG09411522HX, SEG09411523HX, SEG09411524HX, SEG09411525HX, SEG09411526HX, SEG09411527HX, SEG09411528HX, SEG09411529HX, SEG09411530HX, SEG09411531HX, SEG09411532HX, SEG09411533HX, SEG09411534HX, SEG09411535HX, SEG09411536HX, SEG09411537HX, SEG09411538HX, SEG09411539HX, SEG09411540HX, SEG09411541HX, SEG09411542HX, SEG09411543HX, SEG09411544HX, SEG09411545HX, SEG09411546HX, SEG09411547HX, SEG09411548HX, SEG09411549HX, SEG09411550HX, SEG09411551HX, SEG09411552HX, SEG09411553HX, SEG09411554HX, SEG09411555HX, SEG09411556HX, SEG09411557HX, SEG09411558HX, SEG09411559HX, SEG09411560HX, SEG09411561HX, SEG09411562HX, SEG09411563HX, SEG09411564HX, SEG09411565HX, SEG09411566HX, SEG09411567HX, SEG09411568HX, SEG09421619HX, SEG09421620HX, SEG09421621HX, SEG09421622HX, SEG09421623HX, SEG09421624HX, SEG09421625HX, SEG09421626HX, SEG09421627HX, SEG09421628HX, SEG09421629HX, SEG09421630HX, SEG09421631HX, SEG09421632HX, SEG09421633HX, SEG09421634HX, SEG09421635HX, SEG09421636HX, SEG09421637HX, SEG09421638HX, SEG09421639HX, SEG09421640HX, SEG09421641HX, SEG09421642HX, SEG09421643HX, SEG09421644HX, SEG09421645HX, SEG09421646HX, SEG09421647HX, SEG09421648HX, SEG09421649HX, SEG09421650HX, SEG09421651HX, SEG09421652HX, SEG09421653HX, SEG09421654HX, SEG09421655HX, SEG09421656HX, SEG09421657HX, SEG09421658HX, SEG09421659HX, SEG09421660HX, SEG09421661HX, SEG09421662HX, SEG09421663HX, SEG09421664HX, SEG09421665HX, SEG09421666HX, SEG09421667HX, SEG09421668HX, SEG09421669HX, SEG09421670HX, SEG09421671HX, SEG09421672HX, SEG09421673HX, SEG09421674HX, SEG09421675HX, SEG09421676HX, SEG09421677HX, SEG09421678HX, SEG09421679HX, SEG09421680HX, SEG09421681HX, SEG09421682HX, SEG09421683HX, SEG09421684HX, SEG09421685HX, SEG09421686HX, SEG09421687HX, SEG09421688HX, SEG09421689HX, SEG09421690HX, SEG09421691HX, SEG09421692HX, SEG09421693HX, SEG09421694HX, SEG09421695HX, SEG09421696HX, SEG09421697HX, SEG09421698HX, SEG09421699HX, SEG09421700HX, SEG09421701HX, SEG09421702HX, SEG09421703HX, SEG09421704HX, SEG09421705HX, SEG09421706HX, SEG09421707HX, SEG09421708HX, SEG09421709HX, SEG09421710HX, SEG09421711HX, SEG09421712HX, SEG09421713HX, SEG09421714HX, SEG09421715HX, SEG09421716HX, SEG09421717HX, SEG09421718HX, SEG09431720HX, SEG09431721HX, SEG09431722HX, SEG09431723HX…

Recall started

Dec. 20, 2013

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Component change control

What the company told customers

GE Healthcare sent an "Urgent Medical Device Correction" letter dated December 20, 2013 to all affected customers. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter addressed the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Call Technical Support at 1-800-558-7044 or your local Service Representative).

Recall number

Z-0927-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0927-2014. The agency record governs; check it and the company before acting.