BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2090706 · Received April 26, 2011

    Report

    Report Number
    1720753-2011-06596
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 26, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP INSTRUCTED THE CUSTOMER OVER THE PHONE HOW TO REPAIR THE SYSTEM. THE SYSTEM OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN AN ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IRIS WAS TOO LARGE AND THE COLLIMATOR WAS STUCK ON THE 9800 SYSTEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1