BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1903219 · Received November 12, 2010

    Report

    Report Number
    3015876-2010-01250
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 12, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE QUIK-COMBO THERAPY CABLE ASSEMBLY WAS REPLACED AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO THE APEX BEING OPEN FROM END TO END. IT WAS OBSERVED THAT THERE WAS A WIRE PULLED IN THE CABLE NEAR THE DEVICE CONNECTION.

    Description of Event or Problem · 1

    AN (B)(6) CREW WAS DISPATCHED TO THE SCENE OF A PATIENT WHO HAD BEEN VOMITING BLOOD AND COMPLAINING OF CHEST PAIN AT APPROXIMATELY 12:09 ON (B)(6) 2010. THE ALS CREW ARRIVED ON THE SCENE AT APPROXIMATELY 12:18 AND BEGAN THEIR PATIENT ASSESSMENT. THE DEVICE WAS CONNECTED TO THE PATIENT AND THE ALS CREW BEGAN TRANSPORTING THE PATIENT TO THE HOSPITAL AT APPROXIMATELY 13:13, ARRIVING AT APPROXIMATELY 13:20. IT WAS REPORTED THAT WHILE TRANSFERRING THE PATIENT TO THE EMERGENCY ROOM STAFF, HE WENT INTO A VENTRICULAR FIBRILLATION CARDIAC ARREST. THE ALS CREW REPORTED THAT THE DEVICE WOULD NOT ENTER THE PADDLES MODE, SO THEY WERE UNABLE TO ADMINISTER DEFIBRILLATION THERAPY. THE PATIENT OUTCOME AND ADDITIONAL EVENT DETAILS HAVE NOT BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR