BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4180647 · Received October 15, 2014

    Report

    Report Number
    1720753-2014-08667
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 15, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO HAVE THE SVC REP FIX THE SYSTEM. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS DISPLAYED AN OVERLOAD FAULT ERROR MESSAGE FOLLOWED BY A SHUT DOWN OF THE SYSTEM. THERE IS NO REPORT DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653731 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1