BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSHIELDS

    MDR report key: 141583 · Received January 6, 1998

    Report

    Report Number
    MW1012740
    Event Type
    Malfunction
    Date Received
    January 6, 1998
    Date of Event
    November 6, 1997
    Report Date
    December 18, 1997
    Manufacturer
    AIR SHIELDS, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RADIANT WARMER BED MALFUNCTIONED. SMOKING FROM REAR OUTLET AREA. MOVED TO DIFFERENT BED WHEN NOTICED. TEMPERATURE WITHIN NORMAL LIMITS. BIOMED REPLACED POWER OUTLET AND CORD: AIR SHIELDS HAD VOLUNTARILY RECALLED THIS PART, HOWEVER, THE HOSP NEVER RECEIVED THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRSHIELDS RADIANT WARMER BED FMT AIR SHIELDS, INC. PM 78-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY