BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1011856 · Received March 11, 2008

    Report

    Report Number
    1720753-2008-17906
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPAIRED A PIN ON A CONNECTOR OF THE RUI AND CLEANED REGREASED THE HIGH VOLTAGE CABLE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9900 SYSTEM DISPLAYED A CONTACT DETECTED MESSAGE DURING THE CASE. IT WAS ALSO NOTED THAT A LOW MA ERROR WOULD BE DISPLAYED INTERMITTENTLY. ANOTHER SYSTEM HAD TO BE USED TO COMPLETE THE CASE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK