BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 3121046 · Received May 20, 2013

    Report

    Report Number
    3015876-2013-00411
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUBSEQUENTLY TRADED THEIR DEVICE IN AND PHYSIO-CONTROL WAS ABLE TO EVALUATE IT FURTHER. IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U8, ON THE MAIN PCB ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. HOWEVER, THE CUSTOMER DECLINED PHYSIO'S REPAIR OF THE DEVICE. A CONCLUSIVE CAUSE OF THE PROBLEM COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THERE WAS NO FAILURE REPORTED BY THE CUSTOMER. DURING A REGULARLY SCHEDULED PRODUCT MAINTENANCE INSPECTION, PHYSIO-CONTROL FOUND THAT THE DEVICE HAD AN ILLUMINATED SERVICE WRENCH ICON AND A POTENTIALLY CRITICAL EVENT CODE LOGGED IN THE DEVICE MEMORY. THE DEVICE COULD NOT POSSIBLY PROVIDE DEFIBRILLATION THERAPY IN THE REPORTED CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222544 LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1