BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPER HYPOTHERMIA MACHINE

    MDR report key: 2140771 · Received June 15, 2011

    Report

    Report Number
    1313850-2011-00147
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT AND CONCLUSION: IT IS BELIEVED CUSTOMER BLED THE REFRIGERANT OUT OF THE SYSTEM IN ERROR. DEVICE WAS EVALUATED AND NO PRODUCT MALFUNCTION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE UNIT DID NOT COOL. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1