BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3963141 · Received June 19, 2014

    Report

    Report Number
    1720753-2014-05261
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 19, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ON/OFF BUTTON WAS STUCK CAUSING THE SYSTEM TO BE DOWN. THIS COULD PREVENT THE SYSTEM FROM BOOTING UP; RESULTING IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359575 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1