BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1160771 · Received September 8, 2008

    Report

    Report Number
    3015876-2008-01078
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 8, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K890079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO RECOMMENDED CUSTOMER REPLACING THE SYSTEM PCB. THE DEVICE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK DEFIBRILLATOR/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC. 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA