BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVECTIVE PATIENT WARMER

    MDR report key: 2143737 · Received June 3, 2011

    Report

    Report Number
    1313850-2011-00133
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    STRYKER CORP. DBA GAYMAR
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAS NOT YET BEEN RETURNED FOR EVAL AND NO FURTHER INFO IS KNOWN AT THIS TIME. F/U REPORT WILL BE ISSUED AS NECESSARY BASED UPON RESULTS OF INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT FAILED INSPECTION. 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