BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1082769 · Received July 24, 2008

    Report

    Report Number
    3015876-2008-00836
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 27, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND COULD NOT VERIFY THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL CONFIRMED WITH THE CUSTOMER THAT THE DEVICE WAS POWERED DOWN ACCIDENTLY BY THE EMERGENCY MEDICAL TECHNICIAN (EMT) WHO WAS WORKING ON THE PATIENT AT THE TIME. THERE WAS NO DEVICE MALFUNCTION. THE ROOT CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS ATTACHED TO AN UNCONSCIOUS VICTIM WHEN SHOCK WAS ADVISED, HOWEVER, THE DEVICE DID NOT DELIVER THE SHOCK TO THE PATIENT. THE AMBULANCE TOOK OVER PATIENT CARE AND TRANSPORTED TO THE HOSPITAL. THE PATIENT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK