BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAIR HUGGAR PATIENT WARMING SYSTEM

    MDR report key: 221269 · Received April 28, 1999

    Report

    Report Number
    MW1016209
    Event Type
    Other
    Date Received
    April 28, 1999
    Date of Event
    March 16, 1999
    Report Date
    April 16, 1999
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 3/16/99 THE PT, A THREE YEAR-OLD MALE WHO WAS ADMITTED WITH A DIAGNOSIS OF PROFOUND DEAFNESS, UNDERWENT COCHLEAR IMPLANT SURGERY. DURING SURGERY A BAIR HUGGER WARMING BLANKET WAS USED TO KEEP THE CHILD WARM. THE TEMP WAS SET AT 37 DEGREES CELSIUS. SHORTLY AFTER THE WARMING UNIT OF THE BLANKET WAS TURNED ON, IT ALARMED, INDICATING THAT IS WAS OVERHEATING. THE WARMING UNIT WAS TURNED OFF AND REPLACED. UPON ADMISSION TO THE RECOVERY ROOM, THE BAIR HUGGER BLANKET WAS REMOVED FROM THE PT AND HE WAS NOTED TO HAVE A VESICULAR RASH OF BOTH INNER THIGHS, WITH THE LEFT BEING GREATER THAN THE RIGHT. IN ADDITION, THE PT WAS NOTED TO HAVE A RASH ON THE LEFT SIDE OF HIS ABDOMEN AND INNER ASPECT OF HIS LEFT ARM. A PLASTIC SURGERY CONSULTATION WAS OBTAINED AND THE PT WAS DIAGNOSED AS HAVING BLISTERS THAT WERE COMPATIBLE WITH SUPERFICIAL SECOND-DEGREE BURNS FOR WHICH SILVADENE CREAM WAS RECOMMENDED. ON 3/17/99 THE INFANT'S BURNS WERE NOTED TO BE IMPROVED AND HE WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGAR PATIENT WARMING SYSTEM WARMING UNIT DWJ AUGUSTINE MEDICAL, INC. 500/OR UNK
    2 BAIR HUGGAR PATIENT WARMING SYSTEM WARMING UNIT DWJ AUGUSTINE MEDICAL, INC. 500/OR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other BAIR HUGGAR WARMING BLANKET.