GE—B20 and B40 PROCARE Monitors: "V-Tachy" and "V-Fib" Alarms May Be Disabled in Neonatal Mode, Potentially Resulting in Missed Lethal Arrhythmia Alarm
November 14, 2012 | Risk Management News
ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at email@example.com.
In an October 2012 Urgent Field Safety Notice letter posted by the German Federal Institute for Drugs and Medical Devices (BfArM), GE states that the "V Tachy" (ventricular tachycardia) and "V Fib" (ventricular fibrillation) alarms of the monitors below may be disabled in "NEONATAL" mode, potentially resulting in a missed lethal arrhythmia alarm. This problem may lead to a critical event. GE also states that other modes and parameters are not affected by this problem. The manufacturer has not confirmed the...