BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2850562 · Received November 27, 2012

    Report

    Report Number
    1720753-2012-09700
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 27, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE IMAGE INTENSIFIER AND THE POWER CONTROL BOARD WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE LEFT MONITOR WAS NOT FUNCTIONING. THE LEFT MONITOR DISPLAYS THE LIVE FLUOROSCOPY IMAGE. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    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