BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1288 CCU INTERNATIONAL KIT

    MDR report key: 2142574 · Received June 20, 2011

    Report

    Report Number
    2936485-2011-00438
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNIT WAS OPERATING AT AN ABNORMALLY HIGH TEMPERATURE AFTER AN HOUR OF USE. IT WAS FURTHER REPORTED THAT IT WAS OPERATING AT 42 DEGREES CELSIUS AFTER CHECKING THE UNSTABLE IMAGE ON THE SCREEN. IT WAS REPORTED BY THE ACCOUNT THAT THEY BELIEVE THIS TO BE AN ISSUE WHEN THE UNIT IS RUNNING FOR AN EXTENDED PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1288 CCU INTERNATIONAL KIT CCU KOG STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK