BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3123965 · Received May 17, 2013

    Report

    Report Number
    1720753-2013-06148
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE PS1 POWER SUPPLY WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY DISPLAYED A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR MESSAGE LIKELY CAUSED THE SYSTEM TO LOCK UP OR PREVENTED THE SYSTEM FROM BOOTING UP. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219499 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1