BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 6146417 · Received December 5, 2016

    Report

    Report Number
    1720753-2016-03277
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 9, 2016
    Report Date
    January 5, 2017
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    OWB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 LOCKUP WHEN SENDING TO PACS. THE FSE DETERMINED THE CAUSE OF THE PROBLEM TO BE THE SYSTEM HARD DRIVE, BIOS/JAZ(OPTICAL) DRIVE, AND SOFTWARE. THE FSE REPLACED THE HARD DRIVE, RECONFIGURED THE BIOS, DISABLED THE JAZ DRIVE IN THE BIOS, AND RELOADED/UPGRADED SOFTWARE TO RESOLVE THE ISSUE. THE FSE VERIFIED SYSTEM FUNCTIONALITY. 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 IS NOT A MALFUNCTION.

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DISK DRIVE AND ETHERNET PCB WERE EVALUATED AND REPLACED. THE SYSTEM SOFTWARE AND CALIBRATIONS WERE ALSO RELOADED. 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 LOCKED UP. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796787 8800 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1