BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4240030 · Received November 3, 2014

    Report

    Report Number
    1720753-2014-09114
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 17, 2014
    Report Date
    November 3, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SOLID STATE HARD DRIVE WAS EVALUATED AND REPLACED. 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 THE SYSTEM GOT AN ERROR FILE CORRUPTED, SYSTEM NO LONGER USABLE, THE FIELD ENGINEER NOTED THAT THERE WAS A TOTAL LOSS OF IMAGES STORED ON WORKSTATION. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704049 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1