BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3792221 · Received January 13, 2014

    Report

    Report Number
    1720753-2014-00427
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 29, 2013
    Report Date
    January 13, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. THE FSE RECOMMENDED THAT THE BATTERIES BE CHARGED PRIOR TO USE. THE SYSTEM OPERATES AS INTENDED AND WAS RETURNED TO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED A FILAMENT REGULATOR ERROR, WHICH OCCURRED DURING A PROCEDURE WITH PT INVOLVEMENT. THIS MAY HAVE RESULTED IN A POSSIBLE ARO (ACCIDENTAL RADIATION OCCURRENCE). THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33811 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1