BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 1261883 · Received December 15, 2008

    Report

    Report Number
    1720753-2008-21838
    Event Type
    Malfunction
    Date Received
    December 15, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 22, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE SYSTEM HAD A NON-GE X-RAY TUBE. THE SYSTEM WAS FOUND TO BE WITHIN SPECIFICATION, AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600 SYSTEM HAD A PHYSICIST DISCREPANCY. THE DOSE RATE MEASURED HIGH AND THE KVP WAS LOW. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1