BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1193374 · Received October 7, 2008

    Report

    Report Number
    3015876-2008-01462
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 8, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED THERAPY PCB ASSEMBLY WAS EVALUATED BY PHYSIO-CONTROL. THE ROOT CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE A BROKEN FILTER, DESIGNATOR FL6.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING A SERVICE LIGHT AND A FAULT CODE LOGGED INTO DEVICE MEMORY THAT WAS RELATED TO THE THERAPY PCB ASSEMBLY. UPON THE RETURN OF THE REPLACED PCB ASSEMBLY, PHYSIO-CONTROL OBSERVED THAT THE ROOT CAUSE FOR THE SERVICE LIGHT WAS A FAILED COMPONENT THAT COULD CAUSE A FAILURE TO DELIVER DEFIBRILLATOR ENERGY OR A FAILURE TO DELIVER THE APPROPRIATE ENERGY. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA