BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT WARMER

    MDR report key: 25290 · Received September 8, 1995

    Report

    Report Number
    MW1006867
    Event Type
    Malfunction
    Date Received
    September 8, 1995
    Date of Event
    August 19, 1995
    Report Date
    August 24, 1995
    Manufacturer
    AIR-SHIELDS, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFANT TEMPERATURE LOW. WARMER ON, INFANT UNDRESSED & PLACED UNDER WARMER WITH TEMPERATURE PROBE IN PLACE. TEMPERATURE WITHOUT CHANGE AFTER 15 MIN. RECHECKED MACHINE WITH SKILLED CARE NURSERY R.N. INFANT TO SCN FOR WARMING. TEMP IMPROVED IN 1/2 HR. SCN CONTINUED TO ASSESS INFANT & M.D. NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT WARMER WARMER FMT AIR-SHIELDS, INC. MW 78-IN SERIES 4

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other