BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP20

    MDR report key: 1903456 · Received September 20, 2010

    Report

    Report Number
    1903456
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 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 REMAINS ON.MANUFACTURER RESPONSE FOR EXTERNAL DEFIBRILLATOR, LIFEPAK 20:DEFECTIVE MAIN SYSTEM BOARD. THERE IS A CONSISTENT ONGOING BACKORDER DELAY FOR THIS BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP20 EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. LP20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR