BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3902116 · Received February 24, 2014

    Report

    Report Number
    1720753-2014-01775
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 24, 2014
    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 SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HV CABLE CONNECTIONS TO THE X-RAY TUBE WERE EVALUATED, RELUBRICATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS AN 'SATURATION FAULT' ERROR MESSAGE DISPLAYED. THIS ERROR IS LIKELY TO RESULT IN AN IMMEDIATE LOSS OF SYSTEM FUNCTIONALITY AND AN UN-COMMANDED SHUT DOWN. THERE IS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114235 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1