BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIRSHIELDS INFANT WARMER

    MDR report key: 227562 · Received June 16, 1999

    Report

    Report Number
    MW1016547
    Event Type
    Other
    Date Received
    June 16, 1999
    Date of Event
    May 8, 1999
    Report Date
    June 7, 1999
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    FMZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SOLID STATE RELAY BURNED OUT CAUSING SMOKE AND ODOR IN NEWBORN NURSERY AND RESULTING IN EVACUATION OF NURSERY. NOTE THIS IS A SECOND OCCURRENCE IN 16 MONTHS INVOLVING TWO DIFFERENT INFANT WARMING UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRSHIELDS INFANT WARMER INFANT WARMER FMZ HILL-ROM AIR-SHIELDS PM 78-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other