BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2771837 · Received October 2, 2012

    Report

    Report Number
    1720753-2012-07871
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 2, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE CINE BRIDGE, CINE BACKPLANE AND CINE DRIVE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VASCULAR/CINE MODES WOULD NOT PERFORM CORRECTLY. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1