BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVECTIVE PATIENT WARMER

    MDR report key: 2090571 · Received April 19, 2011

    Report

    Report Number
    1313850-2011-00079
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION. FOLLOW-UP WILL BE ISSUED IF NECESSARY BASED UPON INVESTIGATION RESULTS. UNIT WAS REPLACED FOR CUSTOMER IN ADVANCE OF INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAS A BURNING SMELL WHEN IT IS STARTED FOR OPERATION. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVECTIVE PATIENT WARMER PATIENT WARMER DWJ STRYKER CORP DBA GAYMAR TC3146 NA

    Patients

    Seq Age Sex Outcome Treatment
    1