BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1082016 · Received July 22, 2008

    Report

    Report Number
    3015876-2008-00818
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 12, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL IS CURRENTLY EVALUATING THE DEVICE AND CONTINUING TO INVESTIGATE THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    DURING A CARDIOVERSION PROCEDURE, THE DEVICE REPORTEDLY DELIVERED 225 JOULES WHEN SELECTED TO DELIVERY 200 JOULES. THE DEVICE SERVICE INDICATOR ALSO ILLUMINATED. THE DOWNLOADED PT EVENT RECORD INDICATES THAT THE DEVICE POWER SPONTANEOUSLY RESET. THE RECORD INDICATES THAT THERAPY MAY HAVE BEEN DELAYED BECAUSE THE DEVICE MAY HAVE BEEN UNRESPONSIVE FOR APPROX 38 SECONDS.

    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 UNK