BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPER HYPOTHERMIA MACHINE

    MDR report key: 2113422 · Received May 25, 2011

    Report

    Report Number
    1313850-2011-00115
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 26, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF FILING DATE, DEVICE EVALUATION NOT YET COMPLETED. FOLLOW-UP REPORT WILL BE FILED AS NECESSARY BASED UPON INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DID NOT HAVE ANY REFRIGERANT AND WAS NOT COOLING. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPER HYPOTHERMIA MACHINE HYPOTHERMIA MACHINE DWJ STRYKER CORP DBA GAYMAR MTA7900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1