BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3190391 · Received June 26, 2013

    Report

    Report Number
    3015876-2013-00551
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 3, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO THEN OBSERVED THE DEVICE TO NOT HAVE THE ABILITY OF CHARGING AND DELIVERING DEFIBRILLATION ENERGY. THE CAUSE OF THE REPORTED AND OBSERVED FAILURES WAS DETERMINED TO BE A BROKEN (OPEN) STRAP GOING TO ONE OF THE TERMINALS WITHIN THE HIGH ENERGY CAPACITOR. THIS STOPPED THE DEVICE FROM HAVING THE ABILITY TO CHARGE AND DELIVER DEFIBRILLATION ENERGY.THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE WAS SHOWING A SERVICE WRENCH. AFTER AN EVALUATION OF THE DEVICE BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE COULD NOT CHARGE OR DELIVER DEFIBRILLATION ENERGY.THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290814 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1