BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 4130410 · Received September 30, 2014

    Report

    Report Number
    3015876-2014-01148
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. DURING TESTING, IT WAS OBSERVED THAT THE RETAINER CLIP ON ONE OF THE BATTERIES INSTALLED INTO THE DEVICE WAS BROKEN AND WOULD NOT ALLOW THE BATTERY TO LATCH COMPLETELY INTO PLACE IN THE BATTERY WELL. ONCE THE FIRST BATTERY BECAME DEPLETED, THE DEVICE LOST POWER BECAUSE THE SECOND BATTERY WASN'T SEATED COMPLETELY DUE TO THE BROKEN RETAINER CLIP. IT COULD NOT BE CONCLUSIVELY CONFIRMED THAT THIS OCCURRED DURING THE EVENT; HOWEVER, THE EVIDENCE AVAILABLE FROM THE DEVICE EVALUATION INDICATES THAT THIS IS THE LIKELY CAUSE. THE BATTERY WAS REPLACED AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PATIENT EVENT, THE CUSTOMER'S DEVICE LOST POWER MULTIPLE TIMES. IT WAS REPORTED THAT ONCE THE PATIENT'S HUSBAND ARRIVED AT HOME, HE IMMEDIATELY CALLED 911 BECAUSE OF THE PATIENT'S CONDITION. BY THE TIME EMS ARRIVED, THE PATIENT HAD AGONAL BREATHING AND A WAS IN A STATE OF PEA (PULSELESS ELECTRICAL ACTIVITY). THE CUSTOMER'S DEVICE WAS PLACED ON THE PATIENT AND THE PATIENT'S ECG RHYTHM WAS VERIFIED TO BE ASYSTOLE. THE DEVICE THEN LOST POWER ON ITS OWN AND WAS POWERED ON ALMOST IMMEDIATELY. THE DEVICE THEN LOST POWER AGAIN A SHORT TIME LATER. A SECOND DEVICE WAS AVAILABLE IN THE AMBULANCE, HOWEVER WAS NOT PLACED ON THE PATIENT. THE PARAMEDIC ON SCENE REPORTED THE DEVICE DID NOT CONTRIBUTE THE OUTCOME OF THE PATIENT. THE DEVICE WAS THEN TAKEN OUT OF SERVICE. THE PATIENT DID NOT SURVIVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609418 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR