BEUDAMED
    FDA Adverse Event Other Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 1637205 · Received March 19, 2010

    Report

    Report Number
    1723170-2010-00011
    Event Type
    Other
    Date Received
    March 19, 2010
    Date of Event
    September 18, 2009
    Report Date
    September 18, 2009
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    IZL
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INVOLVED. SPECIFICALLY, THE REPLACED PLEORA IPORT BOX IS NOT AVAILABLE FOR EVALUATION. INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A PREVENTIVE MAINTENANCE FIELD SERVICE VISIT FOR AN O-ARM IMAGING SYSTEM, IT WAS NOTED THAT A PLEORA IPORT BOX WAS SUSPECTED TO BE SPORADIC TO SLOW. THE COMPONENT REPLACED CAN AFFECT THE SPEED OF TRANSFER OF IMAGES TO THE MOBILE VIEWING STATION OF THE O-ARM DURING SURGERY. THE PLEORA BOX WAS CHANGED AND UPON COMPLETION OF THE SERVICE, THE SYSTEM WAS OPERATING PROPERLY. THERE ARE NO KNOWN REPORTS FROM THIS USER FACILITY OF PRODUCT PROBLEMS OR ADVERSE EVENTS RELATED TO THIS SPECIFIC PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-ARM 1000 IMAGING SYSTEM MOBILE X-RAY SYSTEM (IZL) IZL MEDTRONIC NAVIGATION BI-700-00027

    Patients

    Seq Age Sex Outcome Treatment
    1