BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3001872 · Received February 12, 2013

    Report

    Report Number
    1720753-2013-01693
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE IGBT SUBBER ASSEMBLY WAS REPLACED AND GENERATOR CALIBRATION WAS PERFORMED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR WAS BLANK DURING FLUOROSCOPY. THE SYSTEM WAS NOT PRODUCTING X-RAY. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62197 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1