BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 2832939 · Received November 15, 2012

    Report

    Report Number
    3015876-2012-00844
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 24, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AT THE FAILURE ANALYSIS CENTER AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THE CAUSE OF THE FAILURE TO BE DUE TO AN OPEN HIGH ENERGY STORAGE CAPACITOR. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE FAILED TO DELIVER ENERGY AT THE 100 JOULE LEVEL DURING TESTING. THE DEVICE WAS ABLE TO DELIVER 360 JOULES. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE. UPON EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE LOGGED MULTIPLE EVENT CODES AND WOULD NOT DELIVER DEFIBRILLATION THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1