BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2201353 · Received August 3, 2011

    Report

    Report Number
    1720753-2011-20673
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 3, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE FLOPPY DRIVE WAS REPAIRED, THE DC VOLTAGE WAS INCREASED, AND THE RIBBON CABLES TO THE CONTROLLER BOARD WERE RESEATED. MONOBLOCK SEASONING WAS PERFORMED TO RELEASE ANY AIR BUBBLES THAT MIGHT HAVE BEEN PRESENT. 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 SYSTEM WOULD NOT PRODUCE FLUOROSCOPIC X-RAYS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1