BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3772150 · Received January 2, 2014

    Report

    Report Number
    1720753-2014-00024
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    December 10, 2013
    Report Date
    January 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND VERIFIED THE CUSTOMERS COMPLAINT. THE FSE RESET THE CB1 CIRCUIT BREAKER, VERIFIED THE BATTERY VOLTAGE, LOAD TESTED THE SYSTEM BATTERIES, CHECKED AND REWORKED THE AC PLUG AND INSPECTED AND RESEATED THE GENERATOR BOARDS AND CONNECTIONS. THE POWER CAPACITOR MODULE AND CB1 WIRING AND CONNECTIONS WAS ALSO INSPECTED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY FAILED TO BOOT TO A USABLE STATE AND EXHIBITED INTERMITTENT FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1