BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2971506 · Received February 4, 2013

    Report

    Report Number
    1720753-2013-01417
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    November 26, 2012
    Report Date
    February 4, 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 SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CONTACTS ON THE C-ARM AND WORKSTATION BOARD WERE CLEANED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE HAVING IMAGE QUALITY ISSUES, BUT WHEN THE FIELD ENGINEER WENT TO CHECK THE SYSTEM, IT WOULD NOT BOOT UP. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47401 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1