BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3126154 · Received May 15, 2013

    Report

    Report Number
    1720753-2013-06071
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 15, 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 SERVICE REPRESENTATIVE EVALUATED THE SYSTEM AND CLEANED AND RE-LUBRICATED THE HIGH VOLTAGE CANDLESTICK CONNECTORS AND PERFORMED A FILAMENT CALIBRATION. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED AN ERROR AND SHUT DOWN ON ITS OWN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215913 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1