BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK

    MDR report key: 10886 · Received January 10, 1994

    Report

    Report Number
    MW1000333
    Event Type
    Malfunction
    Date Received
    January 10, 1994
    Date of Event
    December 17, 1993
    Report Date
    December 22, 1993
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CRITICAL PT'S CONDITION DETERIORATED AND HE ARRESTED. RESUSCITATION WAS ATTEMPTED, AND DEFIBRILLATION WAS ATTEMPTED. DEVICE FAILED TO CHARGE UP AND COULD NOT BE USED TO DEFIBRILLATE PT. A REPLACEMENT DEFIBRILLATOR WAS BROUGHT WITHIN 4 MINUTES. PT DID EXPIRE, BUT INVESTIGATION LED RPTR TO CONCLUDE THAT PT WOULD HAVE DIED REGARDLESS OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK LDD PHYSIO-CONTROL LIFEPAK 6

    Patients

    Seq Age Sex Outcome Treatment
    1 65 *