BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2251181 · Received August 10, 2011

    Report

    Report Number
    3015876-2011-00585
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED EVENT 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 THE DEVICE WOULD ONLY OPERATE WITH FULLY CHARGED BATTERIES. IT WAS INOPERABLE WITH ANYTHING LESS THAN A FULL CHARGE. THE DEVICE ISSUE WAS REPORTED TO HAVE PREVIOUSLY OCCURRED THREE TO FOUR TIMES DURING PT USES WITHOUT ANY ADVERSE EFFECTS. 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. 15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK