BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1061563 · Received June 17, 2008

    Report

    Report Number
    3015876-2008-00614
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD LOSE POWER BY ITSELF, SHORTLY AFTER BEING POWERED ON. PHYSIO PROVIDED THE CUSTOMER WITH AN ESTIMATE OF REPAIRS FOR REPLACING THE POWER CONVERSION PCB ASSEMBLY TO ADDRESS THE REPORTED PROBLEM, BUT THE CUSTOMER DECLINED REPAIR. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    AC AND DC INOPERATIVE. WHEN YOU PUSH THE ON BUTTON, THE GREEN LIGHT COMES ON, THEN WHEN YOU RELEASE THE ON BUTTON, THE GREEN LIGHT GOES OUT AND IT WILL NOT POWER UP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA