BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2935228 · Received January 14, 2013

    Report

    Report Number
    1720753-2013-00636
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, "AT BOOT UP, THERE IS NO EXPOSURE." THE SYSTEM WAS RENDERED UNABLE TO MAKE EXPOSURE. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21163 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1