BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3791774 · Received January 6, 2014

    Report

    Report Number
    1720753-2014-00149
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 20, 2013
    Report Date
    January 6, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND COULD NOT REPRODUCE THE REPORTED PROBLEM. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYS WOULD NOT BOOT UP. 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
    8652 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1