BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIANT WARMER

    MDR report key: 104369 · Received July 9, 1997

    Report

    Report Number
    MW1011655
    Event Type
    Malfunction
    Date Received
    July 9, 1997
    Date of Event
    June 25, 1997
    Report Date
    June 30, 1997
    Manufacturer
    AIR-SHIELDS, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    INFANT WARMER HAD BEEN PLACED ON SERVO MODE - HEATER QUIT. IT WOULD START AGAIN ONLY WHEN TURNED ON AND OFF AND ON AGAIN. THIS HAD HAPPENED NUMEROUS TIMES. INFANTS MAY EXPERIENCE COLD STRESS UNDER THESE CONDITIONS REPEATEDLY. AIR SHIELDS WAS NOTIFIED BY VENDOR AND APPROVED IT BEING PLACED BACK INTO OPERATION. THIS HAS BEEN THE CASE BEFORE AND THERE IS CONCERN OF FUTURE PROBLEMS THAT COULD BE OF A MORE SERIOUS NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANT WARMER RADIANT WARMER FMT AIR-SHIELDS, INC. RW 81- 1 SERIES: 00

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other INFANTS USING WARMERS USUALLY HAVE IV FLUIDS| WITH PUMPS..OTHER EQUIPMENT VARIES WITH EACH CASE.