BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAGER

    MDR report key: 111856 · Received July 3, 1997

    Report

    Report Number
    111856
    Event Type
    Other
    Date Received
    July 3, 1997
    Date of Event
    June 16, 1997
    Report Date
    June 20, 1997
    Manufacturer
    DRAGER, INC.
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 13 DAY-OLD INFANT BABY GIRL WAS RECEIVING A RENAL SCAN WHILE UNDER THE RADIANT WARMER. THE INFANT WAS ON A PLATFORM TO BE SCANNED. THE TEMP PROBE WAS ATTACHED TO THE INFANT'S RIGHT SIDE. THE RIGHT SIDE OF BABY'S TRUNK AND EXTREMITIES AND THE TEMP PROBE WERE NOT DIRECTLY UNDER WARMER DURING THE SCAN. AFTER THE SCAN, ERYTHEMA WITH REDNESS WAS NOTED TO LEFT SIDE OF NECK, TRUNK, LEFT LEG AND GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER RADIANT WARMER FMT DRAGER, INC. BABY THERMOMETER 8000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 DAY Other