BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3000979 · Received February 27, 2013

    Report

    Report Number
    1720753-2013-03181
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 27, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE CINE BRIDGE BOARD, THE CINE DRIVE, THE CINE DRIVE CABLE, AND RELOADED SOFTWARE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A 'CINE DISK NOT AVAILABLE' ERROR UPON BOOT UP. THIS WOULD PREVENT THE CINE FUNCTION FROM OPERATING. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83602 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1