BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3894295 · Received April 23, 2014

    Report

    Report Number
    1720753-2014-03555
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 23, 2014
    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 SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE CINE DRIVE WAS FORMATTED AND THE SOFTWARE WAS INSTALLED DURING THE SERVICE CALL. 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 THAT THE CINE FUNCTION WOULD NOT ALWAYS WORK. IT WAS ALSO REPORTED THAT THE SYSTEM WOULD SHUT DOWN AND FREEZE UP. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. 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
    245204 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1