BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIANT WARMER

    MDR report key: 16254 · Received September 19, 1994

    Report

    Report Number
    MW1003434
    Event Type
    Malfunction
    Date Received
    September 19, 1994
    Date of Event
    August 31, 1994
    Report Date
    September 1, 1994
    Manufacturer
    AIR-SHIELDS VICKERS, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    RADIANT WARMER WAS REPORTED TO HAVE "BURNING SMELL". RPTR OPENED UNIT AND FOUND POWER BOARD BURNT AT THE HEATER ELEMENT CONNECTION POINT. NO DIRECT DANGER TO PT OR STAFF. UNIT WAS NOT BEING USED ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANT WARMER RADIANT WARMER FMT AIR-SHIELDS VICKERS, INC. PM78-1

    Patients

    Seq Age Sex Outcome Treatment
    1 *