BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9 DEFIBRILLATOR/MONITOR

    MDR report key: 1003239 · Received February 21, 2008

    Report

    Report Number
    3015876-2008-00083
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 25, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K881153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT CHARGE THE DEFIBRILLATOR WHEN THE CHARGE BUTTON WAS PRESSED. THE CASE WAS OPENED AND IT WAS OBSERVED THAT THE WELD AT THE ENERGY STORAGE CAPACITOR'S NEGATIVE TERMINAL WAS BROKEN AWAY FROM THE MAIN CAPACITOR BODY AND THAT TIE-WRAPS USED TO SECURE THE CAPACITOR WERE MISSING. PHYSIO REPLACED THE ENERGY STORAGE CAPACITOR AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT CHARGE OR DELIVER ENERGY. THERE WAS NO PT INVOLVED WITH THE REPORTED EVENT.

    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