BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3874670 · Received April 24, 2014

    Report

    Report Number
    1720753-2014-03638
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 24, 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 SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. 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 COLLIMATOR CLOSED DOWN AND WOULD NOT RE-OPEN. THIS RESULTED IN A LOSS OF SYSTEM FUNCTIONALITY. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248309 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1