BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3210089 · Received July 3, 2013

    Report

    Report Number
    1720753-2013-07855
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE POWER SUPPLY VOLTAGE WAS ADJUSTED, AND THE SYSTEM CIRCUIT BOARDS WERE RESEATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED COMMUNICATION ERROR MESSAGES AND REBOOTED WHENEVER THE C-ARM WAS ROTATED TO THE LATERAL POSITION OR OTHERWISE JOLTED. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306601 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1