BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1288 CCU INTERNATIONAL KIT

    MDR report key: 1609663 · Received January 22, 2010

    Report

    Report Number
    2936485-2010-00079
    Event Type
    Malfunction
    Date Received
    January 22, 2010
    Date of Event
    January 11, 2010
    Report Date
    January 11, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE DISPLAYS A GREEN IMAGE. THE CAMERA WAS SENT TO TECHNICAL SERVICES IN (B)(4) AND IT WAS RETURNED WITH INFORMATION THAT THIS SHOULD BE HANDLED AS A PER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1288 CCU INTERNATIONAL KIT CAMERA CONTROL UNIT FXM STRYKER ENDOSCOPY SAN JOSE 09C028734

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK