BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3172214 · Received June 5, 2013

    Report

    Report Number
    1720753-2013-06772
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE PS2 POWER SUPPLY AND WIRE HARNESS WERE REPAIRED. THE P9 CONNECTOR IN THE POWER MOTOR RELAY BOARD WAS 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. THIS ERROR MESSAGE WILL LIKELY CAUSE THE SYSTEM TO LOCK UP FOR SHUT DOWN OR PREVENT THE SYSTEM FROM BOOTING UP. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249246 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1