BEUDAMED
    FDA Adverse Event Summary report: N

    RADIANT WARMER

    MDR report key: 27036 · Received October 11, 1995

    Report

    Report Number
    MW4000909
    Date Received
    October 11, 1995
    Date of Event
    May 8, 1995
    Report Date
    May 10, 1995
    Manufacturer
    AIR-SHIELD VICKERS, INC.
    Product Code
    FMT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELECTRIC CONNECTOR ON MACHINE EMITTED ODOR OF BURNING RUBBER & THEN BURST INTO FLAME-DEVICE IS USED TO WARM INFANTS IN ORDER TO MAINTAIN BODY HEAT WHILE EXPOSED TO TREATMENT UNCOVERED BY BLANKETS OR CLOTHING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other