BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1885296 · Received October 25, 2010

    Report

    Report Number
    1720753-2010-03737
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 25, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY, COLLIMATOR INTERFACE PRINTER CIRCUIT BOARD, AND TABLE GENERATOR INTERFACE WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IT WAS NECESSARY TO RESTART THE SYSTEM CONTINUOUSLY. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1