BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1930063 · Received December 2, 2010

    Report

    Report Number
    1720753-2010-04364
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 30, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE LEMO CONNECTOR WAS REPAIRED AND THE BOARDS AND CONNECTERS WERE RESEATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM HAD INTERMITTENT LOSS OF VIDEO AND THE TECHNIQUE GOES TO MAXIMUM DURING A CASE. THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1