Philips—HeartStart MRx Monitor/Defibrillators: May Fail to Deliver Defibrillation Therapy

April 17, 2013 | Risk Management News

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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 clientservices@ecri.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...

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