BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 6175980 · Received December 15, 2016

    Report

    Report Number
    1720753-2016-03401
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 21, 2016
    Report Date
    December 14, 2016
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    OWB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FLUOROSCOPY FUNCTIONS (FFB) PCB, GENERATOR INTERFACE (GIB) PCB, CONTROL PANEL PROCESSOR PCB AND BACKPLANE WERE EVALUATED AND REPLACED. 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 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
    829173 9800 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS (SLC) 9800 82-0309

    Patients

    Seq Age Sex Outcome Treatment
    1