BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1964692 · Received December 23, 2010

    Report

    Report Number
    3015876-2010-01417
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K955854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REPLACED THE MAIN PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED MAIN PCB ASSEMBLY AND DETERMINED THE CAUSE OF THE MALFUNCTION TO BE FAILURE OF AN IC CHIP, DESIGNATOR U8.

    Description of Event or Problem · 1

    DURING A PERIODIC INSPECTION, IT WAS REPORTED THAT THE DEVICE ILLUMINATED A SERVICE WRENCH. PHYSIO-CONTROL'S INVESTIGATION FOUND THAT THE DEVICE LOGGED AN EVENT CODE IN THE MEMORY AND DISPLAYED THE "CALL SERVICE" MESSAGE INDICATING A CRITICAL FAILURE. THE DEVICE WAS NOT ABLE TO PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE EVENT.

    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