BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3801837 · Received February 11, 2014

    Report

    Report Number
    1720753-2014-01389
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 22, 2014
    Report Date
    February 11, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE AUXILIARY INTERFACE PCB WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FE REPORTED THAT THE SYSTEM INTERMITTENTLY HAD FAILURES BOOTING UP AND PERFORMING FLUOROSCOPY. THIS RESULTS INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90118 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1