BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    98000

    MDR report key: 1860432 · Received September 27, 2010

    Report

    Report Number
    1720753-2010-03223
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 27, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND FOUND THAT THE SYSTEM HAD BROKEN WIRES IN THE HIGH VOLTAGE CABLE. REPLACED THE HV CABLE AND VERIFIED COLLIMATOR AND BEAM ALIGNMENT. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM IS DISPLAYING A COLLIMATOR POTENTIOMETER ERROR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 98000 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1