BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2960850 · Received January 30, 2013

    Report

    Report Number
    1720753-2013-01279
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE HARD DRIVE AND ASSOCIATED CABLING, AND THE SINGLE BOARD COMPUTER WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD INTERMITTENTLY HALT AT 5 ARROWS DURING BOOT UP AND HAVE TO BE REBOOTED. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41425 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1