BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR MONITOR SERIES

    MDR report key: 1080093 · Received July 17, 2008

    Report

    Report Number
    3015876-2008-00807
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 20, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED FAILURE. THE CUSTOMER MENTIONED THAT THE AREA WAS EXPERIENCING POWER SURGES RECENTLY DUE TO WILD FIRES, WHICH COULD BE THE REASON THE DEVICE WAS HAVING INTERMITTENT POWER ISSUES. WHILE EVALUATING THE DEVICE IT WAS OBSERVED THAT THE DEVICE WAS OUT OF CALIBRATION. PHYSIO-CONTROL RECALIBRATED THE DEVICE AND CLEARED ALL THE ERRORS. A SOFTWARE UPGRADE WAS PERFORMED, AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD INTERMITTENTLY TURN ITSELF ON AND OFF. THERE WAS NO PT USE ASSOCIATED WITH THIS EVENT.

    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 NA