BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1001173 · Received February 22, 2008

    Report

    Report Number
    1720753-2008-16379
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 22, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN EVALUATION OVER THE TELEPHONE. ADVISED THE CUSTOMER THAT MOST LIKELY, THE PS3 POWER SUPPLY IS REQUIRED AND NOT THE POWER MOTOR RELAY BOARD. CUSTOMER ORDERED PS3 AND THEY WILL REPLACE. NO SERVICE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIFT COLUMN ON THE 9800 SYSTEM HAS INTERMITTENT PROBLEMS. CUSTOMER INDICATED THE NEED FOR A POWER CONTROL BOARD. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1