BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3801952 · Received February 4, 2014

    Report

    Report Number
    1720753-2014-01150
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 15, 2014
    Report Date
    February 4, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE MAINFRAME SYSTEM BATTERIES WAS EVALUATED AND REPLACED. THE HV CABLE CONNECTIONS WERE ALSO VAPOR PROOFED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    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 WAS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73754 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1