BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1758180 · Received June 29, 2010

    Report

    Report Number
    1758180
    Event Type
    Malfunction
    Date Received
    June 29, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    THE SERVICE LIGHT COMES ON INDICATING AN ERROR CODE FOR LOW COIN BATTERY VOLTAGE. AFTER THE COIN BATTERY IS REPLACED AND THE ERROR CODE IS CLEARED THE SERVICE LIGHT DOES NOT TURN OFF. THE DAILY CHECKS PASS, BUT THE NURSES CANNOT IGNORE THE SERVICE LIGHT BEING ON. PHYSIO-CONTROL STATES THAT THIS IS A PROBLEM WITH THE SYSTEM BOARD. THESE BOARDS ARE ON BACKORDER WITH NO RELEASE DATE.MANUFACTURER RESPONSE FOR EXTERNAL DEFIBRILLATOR, LIFEPAK 20:MAIN SYSTEM BOARD NEEDS TO BE REPLACED (B) (4). THERE ARE NO BOARDS IN STOCK AT PHYSIO-CONTROL AT THIS TIME AND THERE IS NO ESTIMATED TIME FOR WHEN PARTS WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. LIFEPAK 20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *