BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1288 CCU INTERNATIONAL KIT

    MDR report key: 2033094 · Received February 28, 2011

    Report

    Report Number
    2936485-2011-00125
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GREEN LINES APPEARED ON THE SCREEN AND THEN THERE WAS NO IMAGE. IT WAS FURTHER REPORTED THAT THIS HAPPENED INTERMITTENTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK