BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 1000 DEFIBRILLATOR

    MDR report key: 1082828 · Received July 22, 2008

    Report

    Report Number
    3015876-2008-00817
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 14, 2008
    Report Date
    June 16, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE DIGITAL PCB WOULD LOCK-UP. THE ROOT CAUSE OF THIS FAILURE WAS DETERMINED TO BE A FAILURE OF THE CIRCUITRY NEAR A CRYSTAL, DESIGNATOR Y4. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CODE THE DEVICE WAS USED TO DELIVER TWO (2) SHOCKS. AT THAT TIME, THE PARAMEDICS TOOK OVER CARE OF THE PATIENT. DURING THE REMOVAL OF THE DEVICE'S ELECTRODES AND TRANSFER TO PARAMEDICS, THE SCREEN WENT BLANK AND THE DEVICE WOULD NOT POWER OFF. THE REPORTED FAILURE OCCURRED AFTER THE EVENT, AND NOT DURING THE PATIENT CARE. THE PATIENT WAS NOT RESUSCITATED.

    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 UNK