BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9 DEFIBRILLATOR/MONITOR

    MDR report key: 1172745 · Received September 22, 2008

    Report

    Report Number
    3015876-2008-01237
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K881153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL SUPPLIED TROUBLESHOOTING ASSISTANCE AND PARTS INFORMATION TO THE CUSTOMER FOR REPAIR AND REPLACEMENT OF THE POWER CONVERSION PCB ASSEMBLY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE DOES NOT DISPLAY THE ENERGY AVAILABLE, AND AN "ENERGY FAULT" ALARM OCCURS WHEN THE DEFIBRILLATOR IS DISCHARGED INTO A PATIENT SIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 9 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA