BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1883390 · Received October 21, 2010

    Report

    Report Number
    3015876-2010-01157
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 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 EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE MAIN PCB ASSEMBLY WAS REPLACED AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS AN INOPERATIVE IC CHIP, DESIGNATOR U8.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE HAD A FAULT CODE LOGGED IN MEMORY INDICATING A POTENTIALLY CRITICAL FAILURE. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED 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