BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 939096 · Received November 5, 2007

    Report

    Report Number
    1720753-2007-07253
    Event Type
    Malfunction
    Date Received
    November 5, 2007
    Date of Event
    October 10, 2007
    Report Date
    November 3, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE HV CABLE AND RESOLDERED COLD SOLDER JOINT (P3) ON THE COLLIMATOR. REALIGNED CDD CAMERA AND COLLIMATOR TO ADDRESS PHYSICIST ISSUE. 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 9800 SYSTEM DISPLAYED A COLLIMATOR IRIS POT ERROR AND PRESENTED A PHYSICIST DISCREPANCY. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR