BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAIR HUGGER

    MDR report key: 2072114 · Received April 20, 2011

    Report

    Report Number
    2072114
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ARIZANT HEALTHCARE
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    BAIR HUGGER (B) (4) WAS ON HIGH TEMPERATURE BUT WAS BLOWING COLD AIR ACROSS THE PATIENT. THE PATIENT WAS COOLED DURING SURGERY, HAD DECREASED CIRCULATION AND DECREASED TEMPERATURE. THE CASE WAS AN EXTENSIVE THROAT AND MOUTH SURGERY, THE ANESTHESIOLOGIST WAS NOT ABLE TO GET THE PATIENTS FOREHEAD TEMPERATURE W/OUT CONTAMINATING THE FIELD. THE PULSE OX WAS UNABLE TO PICK UP THE O2 LEVEL AT 155. STAFF FELT PATIENT'S HANDS AND DISCOVERED THEN THAT THE PATIENT WAS COLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER BAIR HUGGER PATIENT WARMER DWJ ARIZANT HEALTHCARE 775 BAIR HUGGER *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR