BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3113285 · Received May 8, 2013

    Report

    Report Number
    1720753-2013-05808
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 8, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CONNECTORS AND CIRCUIT BOARDS WERE RESEATED, THE POWER PLUG COMPONENTS WERE RETIGHTENED AND THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED GENERATOR AND COMMUNICATION FAILURE ERROR MESSAGES WHICH CAUSED THE SYSTEM TO LOCK UP. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202310 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1