BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2062074 · Received April 6, 2011

    Report

    Report Number
    1720753-2011-03300
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BOARDS AND CONNECTERS WERE RESEATED. THE CINE BRIDGE WAS REPLACED AND THE POWER SUPPLY WAS ADJUSTED 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

    THE CUSTOMER REPORTED THAT THE 9900 SYSTEM LOCKED UP AND WOULD NOT FLUORO DURING A CASE. ALSO THERE IS AN INTERMITTENT CINE ERROR MESSAGE. THE SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1