BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1120566 · Received August 12, 2008

    Report

    Report Number
    3015876-2008-00939
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 16, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE, AND OBSERVED PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE REPORTED PROBLEM COULD NOT BE REPLICATED, AND THE DEVICE RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    PARAMEDICS RESPONDED TO A PERSON IN CARDIAC ARREST, AND DOWN FOR AN UNK PERIOD OF TIME. ACCORDING TO THE REPORTER, WHILE WORKING ON THE CARDIAC ARREST, A MEDIC NOTICED THE DEVICE HAD POWERED DOWN BY ITSELF, AND HAD TO BE MANUALLY RESTARTED. THE PT WAS NOT RESUSCITATED BUT, UPON REVIEW OF THE PT'S ECG FROM THE DEVICE, THE PT WAS IN ASYSTOLE, AND DID NOT CONVERT TO A SHOCKABLE RHYTHM.

    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