BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 2060779 · Received March 10, 2011

    Report

    Report Number
    2936999-2011-00182
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    DWJ
    PMA / PMN Number
    K913016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011, THAT THE CUSTOMER REPORTED, A PATIENT DEVELOPED RED SPOTS OVER THE BACK POST-OPERATIVELY WHERE THE WARMTOUCH WARMING BLANKET WAS IN PLACE. THE UNIT WAS SENT TO THE HOSPITAL BIOMEDICAL ENGINEERING DEPARTMENT AND WAS TESTED. THE DEVICE WAS FOUND TO OVERHEAT TO 56 DEGREES ON MEDIUM AND HIGH SETTINGS FOR 1 MINUTE. THERE WERE NO ADVERSE LONG TERM PROBLEMS AS FAR AS THE DOCTOR IS AWARE. PATIENT HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARMTOUCH COMPACT WARMING UNIT CONVECTIVE AIR WARMER DWJ COVIDIEN/FORMERLY TYCO 5200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR