BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 5240942 · Received November 20, 2015

    Report

    Report Number
    1720753-2015-04713
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    November 3, 2015
    Report Date
    November 20, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    OWB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FLUOROSCOPY FUNCTIONS (FFB) PCB WAS 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 EXHIBITED AN ERROR, LOCKED UP AND REQUIRED A REBOOT IN AN ATTEMPT TO REGAIN SYSTEM FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771416 9800 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS (SLC) 9800 89-2413

    Patients

    Seq Age Sex Outcome Treatment
    1