BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1012854 · Received March 12, 2008

    Report

    Report Number
    3015876-2008-00170
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 14, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT POWER ON. PHYSIO REPLACED THE POWER PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REPLACED ASSEMBLY, COULD NOT REPLICATE THE REPORTED INCIDENT AND COULD NOT DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    FOUND DURING DAILY TEST. ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT POWER ON. THERE WAS NO PT INVOLVEMENT REPORTED WITH THIS EVENT.

    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