BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4110596 · Received September 16, 2014

    Report

    Report Number
    1720753-2014-07925
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 16, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE AND THE LEMO CONNECTOR WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM PRODUCED UNCOMMANDED X-RAYS DURING A PROCEDURE WITH PT INVOLVEMENT, THEREFORE THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ARO. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572243 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1