BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1188HD CCU

    MDR report key: 2382375 · Received November 17, 2011

    Report

    Report Number
    2936485-2011-00908
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 1, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    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 THE UNIT WENT BLANK DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1188HD CCU CAMERA CONTROL UNIT FXM STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK