BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1031706 · Received April 18, 2008

    Report

    Report Number
    3015876-2008-00356
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 20, 2008
    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

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE DEFIBRILLATOR WOULD NOT TRANSFER ENERGY, THE SVC LIGHT WAS ILLUMINATED AND FAULT CODES RELATING TO ENERGY TRANSFER LOGGED INTO DEVICE MEMORY. PHYSIO OBSERVED THAT A RIBBON CABLE CONNECTING THERAPY PCB ASSEMBLY TO BIPHASIC PCB ASSEMBLY WOULD NOT LATCH INTO CONNECTOR JACK, DESIGNATOR J106, ON THE BIPHASIC PCB BECAUSE J106 WAS BROKEN. PHYSIO REPLACED THE BIPHASIC PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    FOUND DURING INSPECTION. ACCORDING TO THE REPORTER, THE DEVICE DISPLAYED A PERSISTENT SVC ICON. TESTING BY PHYSIO-CONTROL FOUND THAT THE DEVICE DID NOT DELIVER ENERGY. 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