BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2903393 · Received December 14, 2012

    Report

    Report Number
    1720753-2012-10463
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 14, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GPOS, RTOS AND CABLES WERE RESEATED. THE SYSTEM SOFTWARE WAS RELOADED AND THE CINE DRIVE WAS REFORMATTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A FILE SYSTEM CORRUPTED ERROR MESSAGE AND THE ERROR MESSAGE COULD NOT BE CLEARED. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1