BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2083312 · Received April 13, 2011

    Report

    Report Number
    3015876-2011-00322
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 18, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED FAILURE. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. PHYSIO WILL BE RETURNING THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO DELIVER A 200J DEFIBRILLATION SHOCK TO A PATIENT IN VENTRICULAR FIBRILLATION DURING THE FIRST AND SECOND ATTEMPTS. HOWEVER, THE DEVICE DELIVERED A 300J AND 360J SHOCKS TO THE PATIENT DURING THE THIRD AND FOURTH SUBSEQUENT ATTEMPTS RESPECTIVELY. THE PATIENT WAS IN ASYSTOLE ECG RHYTHM THEREAFTER AND DID NOT REQUIRE ADDITIONAL DEFIBRILLATION THERAPY. PHYSIO-CONTROL'S CLINICAL SPECIALIST REVIEW OF THE REPORTED EVENT FOUND THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT OUTCOME.

    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