BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 1881232 · Received October 6, 2010

    Report

    Report Number
    2936999-2010-01248
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 6, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    DWJ
    PMA / PMN Number
    K913016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARMTOUCH 5200 AND 5300 PT WARMER HAVE BEEN DISCONTINUED AND ARE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE CUSTOMER STATED, THEY SMELLED SOMETHING BURNING DURING USE OF THE UNIT FOR AN OPERATION. NO PT HARM REPORTED.

    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