BEUDAMED
    FDA Adverse Event Other Summary report: N

    WARM AIR

    MDR report key: 1082408 · Received July 29, 2008

    Report

    Report Number
    1516825-2008-00004
    Event Type
    Other
    Date Received
    July 29, 2008
    Date of Event
    June 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    CINCINNATI SUB-ZERO
    Product Code
    DWJ
    PMA / PMN Number
    K942790
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES WILL BE SUBMITTED WITH UPDATED REPORT. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT THE WARM AIR UNIT, MODEL 86186 STARTED TO SMOKE IN THE O.R. IN 2008. THE HEALTH AND WELFARE OF THE PT AND HOSPITAL WORKERS WAS REPORTED AS NOT BEING COMPROMISED IN ANY WAY. THE UNIT WAS REMOVED FROM THE OPERATING ROOM AND A REPLACEMENT UNIT WAS SENT TO FACILITY ONE MONTH LATER. THERE HAVE BEEN NO FURTHER OCCURRENCES OF THIS ISSUE REPORTED FROM THIS HOSPITAL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARM AIR HYPERTHERMIA UNIT DWJ CINCINNATI SUB-ZERO

    Patients

    Seq Age Sex Outcome Treatment
    1