BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 1000 DEFIBRILLATOR

    MDR report key: 2152854 · Received June 28, 2011

    Report

    Report Number
    3015876-2011-00501
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 1, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL DETERMINED THE CAUSE OF THE INTERMITTENT POWER ISSUES TO BE FAILURE OF THE MEMBRANE SWITCH ASSEMBLY. AN INTERMITTENT SHORT BETWEEN THE POWER ON/OFF SWITCH AND SOFT KEY TWO RESULTED IN THE OBSERVED FAILURES. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT TURN OFF WITHOUT REMOVING THE BATTERY. PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED INTERMITTENT SPORADIC POWER ISSUES. IT INITIALLY FAILED TO POWER ON AND KEPT POWER CYCLING THEREAFTER UNTIL RESTORATION OF NORMAL OPERATION. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 1000 DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA