BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3010940 · Received March 14, 2013

    Report

    Report Number
    1720753-2013-03777
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND RECOMMENDED THAT THE X-RAY TUBE BE REPLACED, BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM ARCED AND SHUT ITSELF DOWN DURING A PT CASE. UN-COMMANDED SYSTEM SHUTDOWN. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108175 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1