BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3963380 · Received May 30, 2014

    Report

    Report Number
    1720753-2014-04595
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 30, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN WITHOUT COMMAND. 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
    318120 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1