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U.S. Department of Health and Human Services

Class 2 Device Recall GE CARESCAPE Monitor B850

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  Class 2 Device Recall GE CARESCAPE Monitor B850 see related information
Date Initiated by Firm March 08, 2011
Date Posted April 08, 2011
Recall Status1 Terminated 3 on June 05, 2012
Recall Number Z-1929-2011
Recall Event ID 57288
510(K)Number K092027  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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 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. The CARESCAPE Monitor B850 is not intended for use during MRI.
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Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 3817
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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