BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2190585 · Received July 28, 2011

    Report

    Report Number
    3015876-2011-00563
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE; HOWEVER, FOUND IT TO BE A VERY INTERMITTENT FAILURE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PT EVENT, THE DEVICE POWERED ITSELF OFF. THIS LOSS OF POWER OCCURRED TWICE DURING THE PT EVENT, AND THEN A BACK-UP DEVICE WAS PROVIDED, WITH MINIMAL DELAY. THERE WAS NO ADVERSE EFFECT CAUSED TO THE PT FROM A RESULT OF THE REPORTED FAILURE.

    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