BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4122098 · Received September 19, 2014

    Report

    Report Number
    1720753-2014-08022
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 19, 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 ON SITE INVESTIGATION. THE POWER SUPPLY CONNECTIONS AND COIN BATTERY VOLTAGE TO THE GENERATOR INTERFACE PCB ASSEMBLY WERE CHECKED. THE POWER SUPPLY CONNECTIONS TO THE IMAGE INTENSIFIER WERE RESEATED DURING THE SERVICE CALL. REPLACEMENT OF THE PS2 POWER SUPPLY WAS RECOMMENDED TO THE CUSTOMER. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY FAILED TO DISPLAY FLUOROSCOPIC EXPOSURE AND EXHIBITED A 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
    583273 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1