BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1033497 · Received April 23, 2008

    Report

    Report Number
    3015876-2008-00378
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED AN OFFER OF SERVICE FROM PHYSIO-CONTROL. PHYSIO RECOMMENDED THE CUSTOMER REPLACED THE POWER CONVERSION PCB ASSEMBLY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE HAS NO AC OR DC POWER. THERE WAS NO PT ASSOCIATED WITH THE REPORTED EVENT.

    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