BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3823026 · Received February 5, 2014

    Report

    Report Number
    1720753-2014-01177
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 23, 2014
    Report Date
    February 5, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE. A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE VOLTAGE ON POWER SUPPLY WAS EVALUATED AND ADJUSTED TO OPTIMUM OPERATING VOLTAGE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM PRODUCED UNCOMMANDED X-RAYS. THIS EVENT OCCURRED DURING A PROCEDURE WITH PATIENT INVOLVEMENT; THEREFORE, THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ARO (ACCIDENTAL RADIATION OCCURRENCE). THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76114 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1