BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3792577 · Received January 20, 2014

    Report

    Report Number
    1720753-2014-00671
    Event Type
    Malfunction
    Date Received
    January 20, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE AND HV CABLE WERE EVALUATED AND RESEATED. THE FBB, GIB AND HV SUPPLY REGULATORS WERE EVALUATED AND RESEATED. THE FILAMENTS WERE RECALIBRATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS POWERING DOWN IN THE MIDDLE OF CASES. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46465 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1