BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1188 HD CAMERA CONTROL UNIT

    MDR report key: 2220168 · Received August 15, 2011

    Report

    Report Number
    2936485-2011-00590
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE PRODUCT WAS SUBJECTED TO FUNCTIONAL TESTING. NO FAILURES WERE NOTED. THE PRODUCT WAS SUBJECTED TO BURN-IN TESTING USING DIFFERENT CAMERA HEADS, MONITORS, AND ACCESSORIES. NO FAILURES WERE NOTED. THE PRODUCT FUNCTIONED ACCORDING TO ALL SPECS. IN SUM, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT POWERED OFF ON ITS OWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK