BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3170675 · Received June 14, 2013

    Report

    Report Number
    3015876-2013-00508
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A THERMALLY SENSITIVE CRYSTAL, DESIGNATOR Y4 FROM THE DIGITAL PCB ASSEMBLY. THE CRYSTAL WOULD INTERMITTENTLY NOT OSCILLATE WHICH LED TO THE DEVICE NOT POWERING ON NORMALLY. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE DEVICE WAS SHOWING A SERVICE WRENCH ICON AND WOULD NOT SHOW THE BATTERY CHARGE LEVEL CORRECTLY ON THE DISPLAY. THE CUSTOMER LATER ADVISED THAT THE DEVICE APPEARS NOT TO FUNCTION WITH ANOTHER BATTERY INSTALLED. AFTER AN EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE COULD NOT FUNCTION FOR DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271709 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1