BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3101735 · Received April 30, 2013

    Report

    Report Number
    1720753-2013-05496
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 30, 2013
    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

    A GE REP EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. THE CUSTOMER SUBSEQUENTLY FOUND A DAMAGED CONNECTOR ON THE BACK PLANE. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188152 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1