BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1001108 · Received February 14, 2008

    Report

    Report Number
    3015876-2008-00054
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 15, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL IS CONTINUING TO INVESTIGATE THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    FOUND DURING INSPECTION. ACCORDING TO THE REPORTER, THE DEVICE'S SERVICE WRENCH ICON IS FLASHING AND A "CALL SERVICE" MESSAGE IS DISPLAYED. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA