BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1188HD CCU

    MDR report key: 2149637 · Received June 2, 2011

    Report

    Report Number
    2936485-2011-00396
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS NO VIDEO OUTPUT SIGNAL AND THE MONITOR IS BLANK. IT WAS FURTHER REPORTED THAT DURING THE PREPARATION FOR SURGERY, THE TECH FOUND THAT AFTER A FEW MINUTES, THERE WAS NO PICTURE ON THE MONITOR AND THAT THE MONITOR IS BLANK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK