BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3142724 · Received May 24, 2013

    Report

    Report Number
    1720753-2013-06422
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 24, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND REPLACED THE MAINFRAME BACKPLANE. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYS WAS NOT MAKING FLUOROSCOPIC X-RAYS. LOSS OF X-RAY FUNCTIONALITY; THIS IS A REPORTABLE EVENT. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232754 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1