BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4222978 · Received August 6, 2014

    Report

    Report Number
    1720753-2014-06739
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 17, 2014
    Report Date
    August 6, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461710 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1