BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER

    MDR report key: 3965835 · Received July 17, 2014

    Report

    Report Number
    3965835
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    April 8, 2014
    Report Date
    July 17, 2014
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Product Code
    FPL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING OLD BATTERY RELATED TO FAILURE TO CHARGE BECAUSE OF OPEN MAIN FUSE, AS TERMINALS WERE LOOSENED, WIRING HARNESS SHIFTED AND WENT UP IN SMOKE.BIOMED REVIEWED. SHORT FROM POSITIVE BATTERY TERMINAL TO GROUND CAUSED QUICK DISCHARGE OF CURRENT. CONTACT WAS POSSIBLY MADE BY TECH'S WRENCH. TECH SAYS YES IT DID DUE TO HIS REACTION OF THE WIRE GOING UP IN SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420334 VOYAGER INCUBATOR, NEONATAL TRANSPORT FPL INTERNATIONAL BIOMEDICAL, LTD. VOYAGER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 * ITEM WAS NOT BEING USED ON A PATIENT.