BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 2192917 · Received July 22, 2011

    Report

    Report Number
    2936999-2011-00494
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 22, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL ALARM WORKS, THE UNIT IS NOT DESIGNED TO HAVE AN AUDIBLE ALARM. THE THERMISTOR AND POWER CORD ARE REPLACED. THE MFR DATE IS UNK AS THIS IS AN OLD SPARTAN UNIT. IT WOULD HAVE BEEN MANUFACTURED PRIOR TO 2002. THE WT-5800 WARMTOUCH IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, THE WT-5300 WARMTOUCH IS OF ESSENTIALLY IDENTICAL DESIGN AND WAS DISTRIBUTED IN THE U.S. THE 510K NUMBER FOR THE WT-5300 WARMTOUCH IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT WILL HEAT AND WON'T STOP HEATING. WHEN THE TEMPERATURE IS REACHED, THE UNIT WILL NOT HOLD THE TEMPERATURE AND GOES ON HEATING. THE UNIT WON'T COOL BACK TO INPUT VALUES AND THE ALARM IS NOT GIVEN. THERE WAS NO PT HARM, NO PT WAS INVOLVED. THIS WAS FOUND WHEN CHECKING THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1