BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 2143624 · Received June 3, 2011

    Report

    Report Number
    3015876-2011-00445
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K955854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE AND EXPLAINED THE SERVICE OPTIONS FOR THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO FOR FURTHER EVAL. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S DEVICE HAD ITS SERVICE WRENCH ILLUMINATED AND HAD LOGGED A CRITICAL FAULT CODE, WHICH WOULD IMPEDE THE DEVICE'S ABILITY TO DELIVER A DEFIBRILLATION SHOCK. THE DEVICE ALSO LOCKED UP AS IT WAS POWERED UP. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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