BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 1000 DEFIBRILLATOR

    MDR report key: 2251674 · Received August 31, 2011

    Report

    Report Number
    3015876-2011-00646
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ONCE THE DEVICE WAS POWERED ON, IT WOULD CONTINUALLY REBOOT ITSELF UNTIL THE BATTERY WAS REMOVED. THERE WAS NO PT INVOLVEMENT WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 1000 DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA