BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3093407 · Received April 26, 2013

    Report

    Report Number
    1720753-2013-05400
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND CLEANED, LUBRICATED AND RESEATED THE HIGH VOLTAGE CANDLESTICK CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE SYSTEM DISPLAYED A FILAMENT REGULATOR AND KV ON IN ERROR MESSAGES. THIS EVENT OCCURRED OUTSIDE OF THE PROCEDURE AND THERE WAS NO PT INVOLVEMENT. IT IS A REASONABLE EXPECTATION THAT THE SYSTEM WAS NOT ABLE TO PROVIDE ENOUGH POWER TO CREATE EXCESSIVE RADIATION. THE KV ON IN ERROR WILL LIKELY SHUT DOWN WITHOUT COMMAND. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181754 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1