BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 5641517 · Received May 9, 2016

    Report

    Report Number
    1720753-2016-01198
    Event Type
    Malfunction
    Date Received
    May 9, 2016
    Date of Event
    April 15, 2016
    Report Date
    May 18, 2016
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    OWB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THE REPORTED EVENT DETERMINED THAT THERE WAS NO DEVICE MALFUNCTION. THIS IS NOT A REPORTABLE EVENT. COMPLAINT INVESTIGATION: THE FSE CONFIRMED THE PROBLEM REPORTED BY THE CUSTOMER OF SYSTEM WON'T START UP. THE FSE DETERMINED THE CAUSE OF THE PROBLEM TO BE THE SINGLE BOARD COMPUTER(SBC)/CPU. FSE REPLACED THE SBC/CPU TO RESOLVE THE ISSUE. AS A RESULT OF THE SBC BEING REPLACED IT IS ALSO NECESSARY TO COMPLETE AN INITIAL CONFIGURATION TO THE BIOS/CMOS ON THE SBC, TO MAKE IT PROPERLY COMMUNICATE WITH THE SYSTEM. THE FSE VERIFIED SYSTEM FUNCTIONALITY. THE SBC (SINGLE-BOARD COMPUTER) THAT RUNS THE OPERATING SYSTEM. THE SBC PROVIDES OVERALL SYSTEM CONTROL AND OPTIONAL SURGICAL NAVIGATION INTERFACE, OPERATING SYSTEM FOR VIDEO PROCESSING AND CONTROL, AND FOR IMAGE MANAGEMENT. BASED ON AGE OF THE SYSTEM, MANUFACTURED IN 2005, THIS TYPE OF FAILURE WOULD BE EXPECTED AND REFLECTIVE OF THE NORMAL WEAR AND TEAR THAT IS ANTICIPATED AS THE SYSTEM IS USED.

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE COI ASSEMBLY WAS EVALUATED AND IDENTIFIED AS REQUIRING REPLACEMENT. NO CONCLUSION CAN BE DRAWN AS FURTHER SYSTEM ANALYSIS, TESTING OR 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 FAILED TO INITIALIZE. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296407 9800 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1