BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVECTIVE PATIENT WARMER

    MDR report key: 2191577 · Received July 1, 2011

    Report

    Report Number
    1313850-2011-00161
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAS NOT YET BEEN RETURNED TO MFR FOR EVAL. F/U WILL BE FILED AS NECESSARY BASED UPON INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE UNIT NEEDS TO BE REPLACED. 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 TC3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1