BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRTHING ROOM WARMER

    MDR report key: 19290 · Received January 31, 1995

    Report

    Report Number
    MW1004930
    Event Type
    Malfunction
    Date Received
    January 31, 1995
    Date of Event
    January 16, 1995
    Report Date
    January 17, 1995
    Manufacturer
    AIR-SHIELDS VICKERS, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE TURNED WARMER SWITCH ON. NURSE STATED, "IT LOOKED LIKE THE FOURTH OF JULY COMING FROM THE BACK OF THE MACHINE". SHE IMMEDIATELY TURNED MACHINE OFF AND IUNPLUGGED IT FROM WALL. REPORTED TO MFR'S FIELD ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRTHING ROOM WARMER BIRTHING ROOM WARMER FMT AIR-SHIELDS VICKERS, INC. 7865

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other