BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 6042563 · Received October 19, 2016

    Report

    Report Number
    1720753-2016-02847
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 8, 2016
    Report Date
    October 19, 2016
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    OWB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE WORKED WITH THE IN-HOUSE BIOMEDICAL TEAM TO INVESTIGATE THE DEVICE. THE FIELD SERVICE ENGINEER RECOMMENDED REPLACEMENT OF THE CONTROL PANEL PROCESSOR PCB AND THE GENERATOR INTERFACE PCB TO RESOLVE THE REPORTED ISSUE. 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 EXHIBITED AN ERROR. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD SERVICE ENGINEER CONFIRMING THAT THE SYSTEM INTERMITTENTLY FAILED TO BOOT. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690897 9800 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS (SLC) 9800 82-0478-RC

    Patients

    Seq Age Sex Outcome Treatment
    1