Philips—HeartStart MRx Monitor/Defibrillators: May Fail to Deliver Defibrillation Therapy
April 17, 2013 | Strategic Insights for Health System
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 firstname.lastname@example.org.
In an April 2013 Urgent Medical Device Recall letter, Philips states that the monitor/defibrillators below may fail to deliver defibrillation therapy in either manual defibrillation or in automated external defibrillator (AED) mode. If the device fails to deliver defibrillation therapy, it may simultaneously display a "no shock delivered" message along with a "shock equip malfunction" INOP and a red "X" in the ready-for-use (RFU) indicator. The pad's electrocardiograph (ECG) waveform may also display a nonphysiologic flat line rhythm. If this problem occurs, the devices may fail to deliver...