BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAIR HUGGER

    MDR report key: 11259 · Received February 3, 1994

    Report

    Report Number
    MW1000613
    Event Type
    Malfunction
    Date Received
    February 3, 1994
    Date of Event
    January 12, 1994
    Report Date
    January 13, 1994
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    TEMP CONTROL ALARM NOT OPERATING PROPERLY, DEVICE OVER HEATED AND THERE WAS NO ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER DWJ AUGUSTINE MEDICAL, INC. 500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other