GE Healthcare…

Date posted by the FDA

June 11, 2010

Status

Terminated

Filed by

Ge Healthcare, Llc

Product

GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 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 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 (EE), 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.

Reason

GE Healthcare has become aware of a safety issue associated with the CARESCAPE" Monitor B850 when monitoring ECG. The safety issue includes the potential for a delay in treatment.

Distribution pattern

Worldwide distribution: USA including CO, MA, NC, WI, and countries of UNITED KINGDOM, SWITZERLAND, SWEDEN, SPAIN, SINGAPORE, PORTUGAL, NORWAY NETHERLANDS, ITALY, INDIA, GERMANY, FRANCE, FINLAND, BELGIUM, and AUSTRALIA.

Quantity

798 units. (229 USA, 569 OUS)

Codes and lots

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Recall started

May 6, 2010

Device type

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

Root cause (FDA)

Software design

What the company told customers

The customers were sent on May 6, 2010, a GE Healthcare "Urgent Medical Device Correction" letter dated April 22, 2010. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, Director of Biomedical Engineering. The letter listed the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information. The customers were instructed to immediately discontinue use of the "Update Lead Set" function until the device software has been upgraded. If you have any questions regarding this medical device correction or identification of affected items, please contact Technical Support at 1-800-558-7044, or your local service representative.

Recall number

Z-1801-2010

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

Source: FDA · Medical device enforcement report, recall number Z-1801-2010. The agency record governs; check it and the company before acting.