BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 6028767 · Received October 13, 2016

    Report

    Report Number
    1720753-2016-02779
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 21, 2016
    Report Date
    October 13, 2016
    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

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR INTERFACE (GIB) BATTERY, INTERCONNECT CABLE, GENERATOR INTERFACE (GIB) AND X-RAY CONTROLLER PCBS WERE EVALUATED AND REPLACED. 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 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
    679492 9800 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1