BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM

    MDR report key: 65496 · Received December 26, 1996

    Report

    Report Number
    65496
    Event Type
    Other
    Date Received
    December 26, 1996
    Date of Event
    November 20, 1996
    Report Date
    December 17, 1996
    Manufacturer
    PROGRESSIVE DYNAMICS, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SECOND DEGREE THERMAL BURNS TO LEFT HEEL AND RIGHT GREAT TOE FOLLOWING EMERGENCY ABDOMINAL HYSTERECTOMY FOR POST-PARTUM BLEEDING. THE HOSE FROM A LIFE-AIR FORCED AIR WARMER WAS PLACED UNDER COTTON BLANKETS WITH THE OUTLET NEAR THE PT'S FEET DURING THE SURGERY. TEMP SETTING WAS 100 DEGREE F. NO WARMING COVER WAS USED. AT THE CONCLUSION OF SURGERY THE PT'S FEET WERE ERYTHEMATOUS AND PAINFUL AND A BLISTER WAS NOTED ON THE RIGHT GREAT TOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM HYPOTHERMIC THERAPY SYSTEM DWJ PROGRESSIVE DYNAMICS, INC. PD 100-S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other