BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 961534 · Received December 5, 2007

    Report

    Report Number
    3015876-2007-00554
    Event Type
    Malfunction
    Date Received
    December 5, 2007
    Date of Event
    November 6, 2007
    Report Date
    November 6, 2007
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL, INC. IS INVESTIGATING THE DEVICE.

    Description of Event or Problem · 1

    DEVICE WAS TESTED IN AM ON BATTERY. WITHIN AN HOUR, IT WAS CALLED IN FOR USE ON A PT AND WOULD NOT POWER UP ON BATTERY. A BACKUP DEVICE WAS CALLED INTO SERVICE AND THERE WAS NO ADVERSE EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR