GE The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity…

Date posted by the FDA

April 8, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE Monitor B850 host processing unit running the CARESCAPE Monitoring platform software, a display with integrated keyboard and a frame for the insertion of parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader), additional modules and frames and software options. The new subsystems include a host processing unit (CPU), a 15 inch LCD display with an integrated keypad, 19 inch LCD display with an integrated keypad and touch panel interface, a five slot parameter module frame, a seven slot parameter module frame, a cabled remote control, a cabled remote keypad, and the CARESCAPE Monitoring platform software. Some of these new major subsystems include non-patient contact accessory items (e.g. cables and mounting hardware). The CARESCAPE Monitor B850 interfaces to a variety of existing physiological parameter measurement modules. In addition, the CARESCAPE Monitor B850 interfaces to a variety of existing OEM medical devices via the existing network infrastructure. The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. 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 SpO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02…

Reason

GE Healthcare has become aware of potential safety issues associated with the CARESCAPE" Monitor B850 when Patient Data Module (PDM), Tram Acquisition Module (Tram), Patient Side Module (E-PSM or E-PSMP), E- MASIMO or E-(P)RE(S)TN modules or Bed-to-bed alarming feature is used. 1. When CARESCAPE Monitor B850 is used with the above listed modules, some SpO2 alarms may be delayed or missed. 2. Whe

Distribution pattern

Worldwide distribution: USA including states of:AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA,WA, WI, and WV; and countries including: JERUSALEM, UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, QATAR, PORTUGAL, POLAND, NORWAY, NEW ZEALAND, NETHERLAND, MALTA, MALAYSIA, LEBANON, KUWAIT, ITALY, ISRAEL, INDIA, GERMANY, FRANCE, FINLAND, ESTONIA, DENMARK, CZECH REPUBLIC, CHILE , CANADA, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA.

Quantity

3817

Codes and lots

serial numbers: SED07510001GP, SED07510002GP, SED07510003GP, SED07510004GP, SED07510005GP, SED07510006GP, SED07510007GP, SED07510008GP, SED07510009GP, SED07510010GP, SED07510011GP, SED07510012GP, SED07510013GP, SED07510014GP, SED07510015GP, SED07510016GP, SED07510017GP, SED07510018GP, SED07510019GP, SED07510020GP, SED07510021GP, SED07510022GP, SED07510023GP, SED07510024GP, SED07510025GP, SED07510026GP, SED07510027GP, SED07510028GP, SED07510029GP, SED07510030GP, SED07510031GP, SED07510032GP, SED07510033GP, SED07510034GP, SED07510035GP, SED07510036GP, SED07510037GP, SED07510038GP, SED07510039GP, SED07510040GP, SED07510041GP, SED07510042GP, SED08060045GP, SED08060046GP, SED08060047GP, SED08060048GP, SED08060049GP, SED08060050GP, SED08060051GP, SED08060052GP, SED08060053GP, SED08060054GP, SED08060055GP, SED08060056GP, SED08060057GP, SED08060058GP, SED08060059GP, SED08060060GP, SED08060061GP, SED08060062GP, SED08060063GP, SED08060064GP, SED08060065GP, SED08060066GP, SED08060067GP, SED08060068GP, SED08060069GP, SED08060070GP, SED08060071GP, SED08060072GP, SED08070073GP, SED08070074GP, SED08070075GP, SED08070076GP, SED08070077GP, SED08080078GP, SED08080079GP, SED08080080GP, SED08080081GP, SED08080082GP, SED08080083GP, SED08080084GP, SED08080085GP, SED08080086GP, SED08080087GP, SED08080088GP, SED08080089GP, SED08080090GP, SED08080091GP, SED08080092GP, SED08080093GP, SED08080094GP, SED08080095GP, SED08080096GP, SED08080097GP, SED08080098GP, SED08080099GP, SED08080100GP, SED08080101GP, SED08080102GP, SED08080103GP, SED08080104GP, SED08080105GP, SED08080106GP, SED08080107GP, SED08080108GP, SED08080109GP, SED08080110GP, SED08080111GP, SED08080112GP, SED08140113GP, SED08140114GP, SED08140115GP, SED08140116GP, SED08140117GP, SED08140118GP, SED08140119GP, SED08140120GP, SED08150123GP, SED08150124GP, SED08200125GP, SED08200126GP, SED08200127GP, SED08200128GP, SED08200129GP, SED08200130GP, SED08200131GP, SED08210132GP, SED08210133GP, SED08210134GP, SED08210135GP, SED08210136GP, SED08210137GP, SED08210138GP, SED08250153GP, SED08250154GP, SED08250155GP, SED08250156GP, SED08250157GP, SED08250158GP, SED08250159GP, SED08250160GP, SED08250161GP, SED08250162GP, SED08250163GP, SED08250164GP, SED08250165GP, SED08250166GP, SED08290167GP, SED08290168GP, SED08290169GP, SED08290170GP, SED08290171GP, SED08290172GP, SED08290173GP, SED08320174GP, SED08320175GP, SED08370176GP, SED08370177GP, SED08370178GP, SED08370179GP, SED08370180GP, SED08370181GP, SED08370182GP, SED08370184GP, SED08370185GP, SED08370186GP, SED08400187GP, SED08400188GP, SED08400189GP, SED08400190GP, SED08400191GP, SED08400192GP, SED08400193GP, SED08400194GP, SED08400195GP, SED08400196GP, SED08400197GP, SED08400198GP, SED08400199GP, SED08400200GP, SED08400201GP, SED08400202GP, SED08400203GP, SED08400204GP, SED08490205GP, SED08490206GP, SED08490207GP, SED08490209GP, SED08490210GP, SED08490211GP, SED08490212GP, SED08490213GP, SED08490214GP, SED08490215GP, SED08510216GP, SED08510217GP, SED08510218GP…

Recall started

March 8, 2011

Device type

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

Root cause (FDA)

Software design

What the company told customers

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 25, 2011 to its consignees/customers. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letter described the recall product the problem, Safety Issues, Affected Product details, Product Correction, Safety Instructions and Contact Information. The customers were instructed to follow the safety instructions provided in the letter. GE Healthcare is working on a software correction that will be provided to their customers once it is available. If you have any questions regarding this medical device correction or the identification or affected items please contact Technical Support at 1-800-558-7044, or your local Service Representative.

Recall number

Z-1929-2011

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

Source: FDA · Medical device enforcement report, recall number Z-1929-2011. The agency record governs; check it and the company before acting.