BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1821700 · Received August 25, 2010

    Report

    Report Number
    3015876-2010-00963
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 27, 2010
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO NEITHER VERIFY NOR DUPLICATE THE REPORTED FAILURE. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED PROBLEM WAS NOT DETERMINED.

    Description of Event or Problem · 1

    WHILE MONITORING A PEDIATRIC PT DURING TRANSPORT, IT WAS REPORTED THAT THE SCREEN RESET, POWERED ON/OFF BY ITSELF, AND THE ECG READINGS WERE DASHED LINES. THE DEVICE WAS REPORTED TO RESUME NORMAL OPERATION SEVERAL SECONDS THEREAFTER. THERE WAS NO ADVERSE EVENT REPORTED AS THE RESULT OF THE DEVICE USE. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PT PROVIDED.

    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