BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3964767 · Received June 19, 2014

    Report

    Report Number
    1720753-2014-05203
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 18, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. AS A PRECAUTION, THE CINE BRIDGE PCB AND ASSOCIATED CABLING WERE RESEATED. THE CINE DRIVE WAS REFORMATTED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CINE DISK NOT AVAILABLE ERROR MESSAGE. THIS WOULD PREVENT THE CINE FUNCTION FROM OPERATING, CAUSING A LOSS OF SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR FUNCTIONS. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360842 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1