BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1060525 · Received June 11, 2008

    Report

    Report Number
    3015876-2008-00590
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL IS CONTINUING TO INVESTIGATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE SERVICE INDICATOR DISPLAYS AN ALARM SOUND WHEN THE DEFIBRILLATOR IS CHARGED. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORT.

    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