BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 6136857 · Received November 30, 2016

    Report

    Report Number
    1720753-2016-03234
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 3, 2016
    Report Date
    January 24, 2017
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    OWB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 PROBLEM REPORTED BY THE CUSTOMER WAS THE SYSTEM MONITOR TURNING OFF AND ON THEN SHUTTING DOWN. THE FSE DETERMINED THE CAUSE OF THE PROBLEM TO BE FAULTY CPU PCB. THE FSE REPLACED CPU, REPLACED HARD DRIVE, UPDATED SOFTWARE AND VERIFIED SYSTEM FUNCTIONALITY. THE CPU (CENTRAL PROCESSING UNIT) RUNS THE OPERATING SYSTEM. THE CPU PROVIDES OVERALL SYSTEM CONTROL; OPTIONAL SURGICAL NAVIGATION INTERFACE; THE OPERATING SYSTEM FOR VIDEO PROCESSING/ CONTROL AND FOR IMAGE MANAGEMENT. FAILURE OF THE CPU CAN CAUSE SYSTEM TO SHUTDOWN. REPLACING THE CPU RESOLVES THIS ISSUE. REPLACING HARD DRIVE DUE TO FAILURE OF PREVIOUS DRIVE. BASED ON AGE OF THE SYSTEM, MANUFACTURED BEFORE 2006, THIS TYPE OF FAILURE WOULD BE EXPECTED AND REFLECTIVE OF THE NORMAL WEAR AND TEAR THAT IS ANTICIPATED AS THE SYSTEM IS USED. THIS COMPLAINT DOES NOT REPRESENT A MALFUNCTION.

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CPU ASSEMBLY WAS EVALUATED AND REPLACED. THE HARD DISK DRIVE WAS ALSO REPLACED AND THE SYSTEM SOFTWARE WAS UPGRADED. 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 EXPERIENCED AN IMMEDIATE LOSS OF SYSTEM FUNCTIONALITY AND COULD NOT BE REBOOTED. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786252 8800 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1