HGE Healthcare Patient Monitor B30…

Date

Dec. 18, 2013

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

HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, EGG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esosophageal/Nasopharyngeal/Tymnpanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, and functional oxygen saturation (Sp0 2) and pulse rate via continuous monitoring , including monitoring during conditions of clinical patient motion or low perfusion. K120598 (Procare Monitor B40): The PROCARE Monitor 840 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympaiic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion. K130584 (Monitor B40): The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy. Product Quantity Distributed (Int) 16,061 (343 US, 15,718 OUS)

Reason

GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors. The B20, B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter, an additional 0.5 Hz high pass filter is used. The

Distribution pattern

Worldwide Distribution - USA (nationwide) to CA, CT, FL, GA, MO, NC, NJ, PA, TX, WI and Internationally to: FRANCE, PORTUGAL, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA 7 HERZEGOVINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, NEW ZEALAND, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, COTE DLVOIRE, CROATIA, CYPRUS,. CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, GABON, GERMANY, GREECE, GUATEMALA, HONDURAS, HUNGARIA, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, MYAMMARA, NAMBIA, NAPAL, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SENEGAL SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SIR LANKA, SWEDEN, SWITZERLAND, THAILAND, THE NETHERLANDS, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, URUGUAY, UZEBEKISTAN, VENEZUELA, and VIETNAM.

Quantity

16,061 (343 US, 15,718 OUS)

Codes and lots

Mfg Lot or Serial # SG212501463WA SG213142063WA SG212491284WA SG212491286WA SG212491320WA SG212491328WA SG213091890WA SG213142034WA SG213142065WA SG213172123WA SG213172126WA SG213172141WA SF311283756WA SF312205556WA SG212190622WA SG212190623WA SG212190624WA SG212190625WA SG212190626WA SG212190627WA SG212190628WA SG212190629WA SG212190630WA SG212190631WA SG212160603WA SG212160606WA SG212230660WA SG212260716WA SG212260735WA SG212260737WA SG212260739WA SG212270742WA SG212270747WA SG212491329WA SG212491346WA SG212421031WA SG212431128WA SG212421034WA SG213021574WA SG213031688WA SG212521557WA SG212521545WA SF312396183WA SF312396187WA SF312396189WA SF312396190WA SF312396191WA SF312396192WA SF312396193WA SG213142038WA SG212521547WA SG213021582WA SG213021585WA SG213031681WA SG213031683WA SG213031684WA SG213031685WA SG213031687WA SG213031689WA SF310200786WA SF310200788WA SG212521544WA SG212521546WA SG212521548WA SG212521549WA SG212521550WA SG212521551WA SG212521552WA SG212521553WA SG212521554WA SG212521555WA SG212521556WA SG212521558WA SG212521559WA SG212521560WA SG212521561WA SG212521563WA SG212521564WA SG212521565WA SG213021570WA SG213021571WA SG213021572WA SG213021573WA SG213021575WA SG213021576WA SG213021577WA SG213021579WA SG213021580WA SG213021581WA SG213021583WA SG213021584WA SG213021612WA SG213021614WA SG213021615WA SG213021617WA SG213021618WA SG213021619WA SG213021620WA SG213021621WA SG213021622WA SG213021626WA SG213021627WA SG213021630WA SG213031631WA SG213031632WA SG213031634WA SG213041690WA SG213041691WA SG213041692WA SG213041709WA SG213041712WA SG213041714WA SG213041715WA SG213041723WA SG213041724WA SG213041725WA SG213041726WA SG213041727WA SG213041728WA SG213041729WA SG213041730WA SG213041731WA SG213041732WA SG213041733WA SG213041734WA SG213101906WA SG213132003WA SG213132015WA SG213142039WA SG213142040WA SG213142041WA SG213142042WA SG213142044WA SG213142045WA SG213142046WA SG213142049WA SG213142051WA SG213142055WA SG213142057WA SG213142058WA SG213142060WA 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SGF13025337WA SGF13025338WA SGF13025339WA SGF13025340WA SGF13035372WA SGF13035373WA SGF13035374WA SGF13035375WA SGF13045480WA SGF13045481WA SGF13045482WA SGF13045483WA SGF13045484WA SGF13045486WA SGF13045487WA SGF13045488WA SGF13045489WA SGF13045490WA SGF13045491WA SGF13045492WA SGF13045493WA SGF13045494WA SG213031668WA SG213031669WA SG213031670WA SG213031671WA SG213031672WA SG213031673WA SG213031674WA SG213031675WA SG213031676WA SG213031677WA SG213031678WA SG213031680WA SG213031682WA SG213031686WA SGF13025316WA SGF13025341WA SGF13025342WA SGF13025343WA SGF13035434WA SGF13035435WA SGF13035437WA SGF13035439WA SGF13035440WA SGF13035441WA SGF13035442WA SGF13035443WA SGF13035444WA SGF13035445WA SGF13035446WA SG212521562WA SG213021578WA SG213021616WA SG213131996WA SG213131997WA SG213131999WA SG213132001WA SG213132002WA SG213132009WA SG213132010WA SG213132011WA SG213132012WA SG213132013WA SG213132014WA SG213132016WA SG213132017WA SG213132018WA SG213132020WA SG213132021WA SG213132022WA 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SG212230621WA SG212230649WA SG212230650WA SG212230651WA SG212230652WA SG212230653WA SG212230654WA SGF12112127WA SGF12142271WA SGF12142275WA SGF12142279WA SGF12152341WA SGF12162449WA SGF12172486WA SGF12172494WA SGF12172563WA SGF12172568WA SGF12172571WA SGF12172596WA SGF12232672WA SGF12142330WA SGF12021263WA SG211500215WA SG211500220WA SG211500221WA SG211500224WA SG211500225WA SGF12112132WA SGF12122209WA SGF12263175WA SGF12122213WA SGF12122219WA SF311223400WA SF310200752WA SF310190695WA SF309470108WA SF310502384WA SGF12474420WA SGF12474390WA SGF12494745WA SF311324700WA SF313147104WA SF313177118WA SF312155330WA SF312155331WA SF310472224WA SF309530232WA SF310220822WA SF310230938WA SF311263715WA SF312105229WA SF312155276WA SF310271108WA SF309250001WA SF310060338WA SF310060344WA SF310060351WA SF310060352WA SF310512413WA SF311112949WA SF310411773WA SGF13176730WA SG212491417WA SG212421091WA SG212491377WA SG212491416WA SG212491420WA SG212491424WA SG212501432WA SG212501433WA SG212501438WA 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SG212421045WA SG212421046WA SG212421047WA SG212421048WA…

Recall started

Oct. 11, 2013

Device type

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

Root cause (FDA)

Software design

What the company told customers

GE Healthcare sent an Urgent Medical Device Correction letter dated October 10, 2013, to all affected consignees. The letter described the safety Issue, Safety Instructions, Affected Product, Details, Product Correction and Contact Information (Technical Support at 1-800-558-7044).Consignees were asked to retain a copy of the instructions with the user manual. For questions regarding this recall call 262-513-4122.

Recall number

Z-0489-2014

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

Source: FDA · Medical device enforcement report, recall number Z-0489-2014. The agency record governs; check it and the company before acting.