BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3093405 · Received April 26, 2013

    Report

    Report Number
    1720753-2013-05402
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE INTERCONNECT CABLE AND THE LEMO CONNECTOR. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CUSTOMER MOVES THE C-ARM IN A LATERAL POSITION, THE IMAGES GO BLANK. THIS WOULD CAUSE THE SYSTEM TO BECOME INTERMITTENTLY UNUSABLE DUE TO THE LOSS OF LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181867 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1