BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1188HD CCU

    MDR report key: 1458159 · Received May 21, 2009

    Report

    Report Number
    2936485-2009-00046
    Event Type
    Malfunction
    Date Received
    May 21, 2009
    Date of Event
    April 22, 2009
    Report Date
    April 22, 2009
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED, ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGE WAS SHAKING UNCONTROLLABLY. ALLEGEDLY, ADD'L ANESTHESIA HAD TO BE ADMINISTERED. ADDITIONALLY, IT WAS REPORTED THAT A LOANER CONSOLE AND CAMERA HEAD WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1188HD CCU CCU FXM STRYKER ENDOSCOPY SAN JOSE 08K009874

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK