BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2232914 · Received July 28, 2011

    Report

    Report Number
    3015876-2011-00555
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 2, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED LOCK UP FAILURE. HOWEVER, THE DEVICE OPERATED NORMALLY AFTER IT WAS TAKEN APART AND REASSEMBLED. THE LOCK UP FAILURE WAS NOT DUPLICATED DURING FURTHER TESTING. PROPER DEVICE OPERATION WAS CONFIRMED THRU FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE RETURNED TO THE CUSTOMER FOR USE. FURTHER CAUSE OF THE OBSERVED/REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING A PT USE, IT WAS REPORTED THAT THE DEVICE LOST POWER AND IT WOULD NOT ADVANCE PAST THE PASS-CODE SCREEN UPON BOOT UP. THE DEVICE WAS MONITORING A MOTOR ACCIDENT PT WITH HEAD INJURIES WHILE BEING TRANSPORTED TO HOSPITAL. THE 12 LEAD ECG, BLOOD PRESSURE AND CARTOON DIOXIDE PARAMETERS WERE RUNNING WHEN THE OPERATOR PRESSED THE PRINT BUTTON AND THE DEVICE LOST POWER. THE DEVICE LOCKED UP UPON POWER ON AND REMAINED UNAVAILABLE FOR USE FOR THE NEXT 20 MINUTES. DURING THIS TIME, THE HEALTH PROFESSIONAL CONFIRMED THAT THE PT WAS VIABLE AND DID NOT REQUIRE INTERVENTION THERAPY. 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 15 MONITOR/DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR