BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3101574 · Received May 1, 2013

    Report

    Report Number
    1720753-2013-05515
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 1, 2013
    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 SVC REP PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR CIRCUIT BOARDS WERE RESEATED AND A FILAMENT AND GENERATOR CALIBRATION WAS PERFORMED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED. THIS MALFUNCTION WAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS DISPLAYED A FILAMENT REGULATOR ERROR MESSAGE DURING A PT PROCEDURE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190185 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1