BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 6234676 · Received January 9, 2017

    Report

    Report Number
    1720753-2017-00086
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 15, 2016
    Report Date
    February 17, 2017
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    OWB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SBC (SINGLE BOARD COMPUTER) CPU ASSEMBLY WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    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 NO BOOT. THE FSE DETERMINED THE CAUSE OF THE PROBLEM TO BE A FAULTY SBC, WHICH CAUSED THE SYSTEM TO LOSE ITS CMOS SETTINGS. THE SBC (SINGLE-BOARD COMPUTER) RUNS THE OPERATING SYSTEM. THE SBC PROVIDES OVERALL SYSTEM CONTROL; OPTIONAL SURGICAL NAVIGATION INTERFACE; THE OPERATING SYSTEM FOR VIDEO PROCESSING/ CONTROL AND FOR IMAGE MANAGEMENT. THE SBC RETAINS THE CMOS SETTINGS, WHICH ARE BASIC FIRMWARE SETTINGS. IF THEY GET CORRUPTED OR LOST, THE SYSTEM WILL NOT BOOT UP. FSE REPLACED THE FAULTY SBC TO RESOLVE THE ISSUE (FSE HAD TO INSTALL THE SBC UPGRADE KIT TO REPLACE OBSOLETE COMPONENTS INCLUDING THE MONOBLOCK CONTROLLER SO THEY WOULD BE COMPATIBLE WITH THE NEW SBC). BASED ON AGE OF THE SYSTEM (LAST MANUFACTURED IN 2006), THIS TYPE OF FAILURE WOULD BE EXPECTED AND REFLECTIVE OF THE NORMAL WEAR AND TEAR THAT IS ANTICIPATED AS THE SYSTEM IS USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM FAILED TO BOOT UP. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16517 8800 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS (SLC) 8800 FIB-0035

    Patients

    Seq Age Sex Outcome Treatment
    1