BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 3201740 · Received July 2, 2013

    Report

    Report Number
    3015876-2013-00566
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL DIDN'T EVALUATE THE DEVICE. A THIRD PARTY AGENT EVALUATED THE DEVICE AND VERIFIED THAT THE DEVICE SWITCHED ITSELF OFF AFTER THE DEVICE CHARGED ENERGY. IT WAS OBSERVED THAT THE DEVICE DIDN'T SHOW THE OK SIGN IN THE DEVICE READINESS DISPLAY AND THAT THE LOW BATTERY INDICATOR WAS SHOWING. THEN HE REPLACED THE DEVICE'S BATTERY. AFTER OBSERVING PROPER DEVICE OPERATION, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE DEVICE'S SELF-TEST LOG SHOWED THAT THE DEVICE INDICATED THE DEVICE LOW BATTERY LEVEL FOR ALMOST TWO MONTHS; THEREFORE THE USER SHOULD HAVE REPLACED THE BATTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE DEVICE TURNED ITSELF OFF. THE DEVICE SHOWED THE OK SIGN IN THE DEVICE READINESS DISPLAY BEFORE USE BUT AS THE DEFIBRILLATION ENERGY WAS CHARGING, THE DEVICE SWITCHED OFF AND WOULD NOT SWITCH BACK ON. CPR WAS PERFORMED ON THE PATIENT AND UPON ARRIVAL OF THE AMBULANCE, THE PATIENT WAS SUCCESSFULLY SHOCKED WITH ANOTHER DEVICE. THE PATIENT RETRIEVED HIS HEART RHYTHM AND WAS TRANSPORTED TO THE HOSPITAL. THERE IS NO REPORTED ADVERSE OUTCOME FOR THE PATIENT. AFTER THE EVENT, THE DEVICE WAS ABLE TO SWITCH ON THE LOW BATTERY ICON SHOWED IN THE DEVICE READINESS DISPLAY. THE DEVICE BATTERY'S EXPIRATION DATE IS 19 JUNE 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301724 BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR