BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE-AIR 1000

    MDR report key: 103775 · Received July 1, 1997

    Report

    Report Number
    103775
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    April 23, 1997
    Report Date
    April 23, 1997
    Manufacturer
    PROGRESSIVE DYAMICS, INC
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LIFE-AIR 1000 WAS USED IN ORDER TO WARM THE PATIENT DURING SURGERY. THE BLOWER HOSE WAS NOT CONNECTEED TO A WARMING COVER. AT THE END OF SURGERY, A 2% TBSA SECOND DEGREE BURN WAS NOTED ON THE PT'S RIGHT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE-AIR 1000 HYPOTHERMIC SYSTEM DWJ PROGRESSIVE DYAMICS, INC PD-1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention