BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4214066 · Received October 24, 2014

    Report

    Report Number
    1720753-2014-08893
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CONNECTORS WERE RESEATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED, FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED COMMUNICATION FAIL ERROR MESSAGES AND WAS DOWN. THERE ARE NO REPORTS OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679013 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1