BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2043614 · Received March 29, 2011

    Report

    Report Number
    3015876-2011-00280
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND REPLACED THE POWER PCB ASSEMBLY. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE LOANER POOL FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED POWER PCB ASSEMBLY AND DETERMINED THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A SHORTED CAPACITOR, DESIGNATOR (B)(4).

    Description of Event or Problem · 1

    IT WAS OBSERVED THAT THE PHYSIO LOANER DEVICE WOULD NOT POWER ON WITH AC OR DC POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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 NA