BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4142799 · Received September 30, 2014

    Report

    Report Number
    1720753-2014-08296
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 30, 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 REP EVALUATED THE SYS BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYS WOULD NOT FULLY BOOT. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THE COMPLAINT. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607193 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1