BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/PACEMAKER

    MDR report key: 1594307 · Received January 27, 2010

    Report

    Report Number
    3015876-2010-00112
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    December 28, 2009
    Report Date
    December 28, 2009
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). PHYSIO-CONTROL RECOMMENDED THE REPLACEMENT OF THE (B) (4) SMARTWATCH IC U28 AND THEN TO RECALIBRATE THE DEVICE AND PERFORM A PERFORMANCE INSPECTION PROCEDURE. THE PART NUMBER FOR THE IC WAS PROVIDED TO THE CUSTOMER. THE CUSTOMER LATER CONFIRMED THAT THE DEVICE HAS BEEN REPAIRED BY REPLACING IC U28 ON THE MAIN PCB. IT WAS INDICATED THAT PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS PLACED BACK INTO SERVICE FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE GIVES AN ENERGY FAULT MESSAGE AND THE SERVICE INDICATOR IS ON. IT WAS ALSO NOTED THAT WHEN TRYING TO SHOCK AT 50 JOULES, THE DEVICE WOULD INTERMITTENTLY NOT DELIVER A SHOCK. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA