BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAN 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 961527 · Received December 5, 2007

    Report

    Report Number
    3015876-2007-00563
    Event Type
    Malfunction
    Date Received
    December 5, 2007
    Report Date
    November 7, 2007
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL INC. CONTINUES TO INVESTIGATE THE REPORTED EVENT. AWAITING RETURN OF THE DEVICE FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DEFIBRILLATION ENERGY LEVELS WOULD NOT REMAIN CALIBRATED AND THE HIGHER DEFIBRILLATOR ENERGY SELECTIONS WOULD NOT FUNCTION PROPERLY. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR