BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1468016 · Received June 11, 2009

    Report

    Report Number
    3015876-2009-00794
    Event Type
    Malfunction
    Date Received
    June 11, 2009
    Date of Event
    May 12, 2009
    Report Date
    May 12, 2009
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). PHYSIO-CONTROL PROVIDED CUSTOMER WITH THE U28 PART NUMBER INFORMATION FOR THE REPAIR OF THE DEVICE. THE CUSTOMER LATER CONFIRMED THAT REPLACEMENT OF THE U28 CHIP ON THE MAIN PCB HAD RESOLVED THE PROBLEM AND THE DEVICE IS FUNCTIONING PROPERLY. THE DEVICE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION. FURTHER ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE POWERED ON IN EITHER THE SYNC OR PACE MODES AND THEY WERE UNABLE TO EXIT FROM THESE. THE CUSTOMER WAS UNABLE TO ACCESS THE TEST MENU TO CHECK FOR ERROR CODES, AND WAS UNABLE TO PRINT AND ACCESS THE DATE AND TIME INFORMATION. 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/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC. 9P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA