BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4180675 · Received October 15, 2014

    Report

    Report Number
    1720753-2014-08657
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 15, 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

    A GE REPRESENTATIVE EVALUATED THE SYSTEM BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED THE SYSTEM DID NOT POWER UP. THIS RESULTED INA TOTAL LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE THE DEADLY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654891 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1