BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3231064 · Received July 12, 2013

    Report

    Report Number
    1720753-2013-08076
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CINE DISK WAS REPLACED, AND THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A CINE DISK NOT AVAILABLE ERROR MESSAGE, WHICH RESULTED IN A LOSS OF SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321951 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1