BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1033055 · Received April 23, 2008

    Report

    Report Number
    3015876-2008-00374
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL REPLACED THE DEVICE. PHYSIO EVALUATED THE DEVICE AND OBSERVED A FAULT CODE RELATED TO MOTION DETECTION FUNCTION LOGGED INTO DEVICE MEMORY BUT COULD NOT REPLICATE THE FAULT CODE AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    FOUND DURING INSPECTION, ACCORDING TO THE REPORTER, THE DEVICE DISPLAYED A SVC WRENCH ICON. THERE WAS NO PT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA