BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAIR HUGGER

    MDR report key: 41055 · Received September 30, 1996

    Report

    Report Number
    41055
    Event Type
    Malfunction
    Date Received
    September 30, 1996
    Date of Event
    May 13, 1996
    Report Date
    September 27, 1996
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SURGICAL PROCEDURE WITH FORCED AIR PT WARMER IN PLACE. EQUIPMENT ALARMED DURING PROCEDURE - EQUIPMENT TURNED OFF AND REMOVED. FOLLOWING THE PROCEDURE, SEVERAL RED AREAS NOTED ON PT'S RIGHT LEG. EXAMINATION REVEALED 1ST DEGREE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER FORCED AIR PATIENT WARMER DWJ AUGUSTINE MEDICAL, INC. 500/OR *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR