BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAIR HUGGER

    MDR report key: 514096 · Received February 24, 2004

    Report

    Report Number
    MW1031289
    Event Type
    Malfunction
    Date Received
    February 24, 2004
    Date of Event
    January 6, 2004
    Report Date
    February 14, 2004
    Manufacturer
    AUGUSTINE MEDICAL INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT TEMPERATURE ELEVATED WHILE BAIR HUGGER OFF. BAIR HUGGER TURNED TO AMBIENT MODE, OVER TEMP ALARM SOUNDED AFTER APPROX 20 MINUTES. NO THERMAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER WARMER DWJ AUGUSTINE MEDICAL INC. 5000R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *