BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2021892 · Received February 25, 2011

    Report

    Report Number
    1720753-2011-01695
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 25, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP PERFORMED AN ON SITE INVESTIGATION. THE JOYSTICK DETECTOR HAS BEEN ORDERED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM'S JOYSTICK WAS NOT WORKING. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1