BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 1081477 · Received July 25, 2008

    Report

    Report Number
    2936999-2008-00365
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTH
    Product Code
    BSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARMTOUCH 5200 PT WARMER HAS BEEN DISCONTINUED AND IS BEING REPLACED WITH A NEW DESIGNED WARMTOUCH PT WARMER. ACTIVE CUSTOMERS HAVE BEEN NOTIFIED OF THE AVAILABILITY OF THE NEW 5300A MODEL WHICH ADDRESSES THE POTENTIAL FAILURE MODE. RETURN OF THIS UNIT FOR INVESTIGATION WAS REQUESTED. IF THE DEVICE IS RETURNED, AND THERE IS ANY SIGNIFICANT NEW INFO A SUPPLEMENTAL WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING USE, SMOKE CAME FROM THE WARMTOUCH UNIT AND INSIDE OF BLANKET WAS DISCOLORED BLACK WITH SOMETHING LIKE SMOKE DUST. BURNING SMELL FILLED THE OR ROOM. THE POWER CABLE WHICH WAS USED AT THE TIME OF EVENT WAS NOT GENUINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARMTOUCH COMPACT WARMING UNIT CONVECTIVE AIR WARMER BSB COVIDIEN/FORMERLY TYCO HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention