BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 2081166 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00861
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    IZL
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO AS NO PT WAS PRESENT IN THIS CONCERN. DEVICE MANUFACTURE DATE IS UNK. THIS IS A DEMO SYSTEM AND WOULD NOT BE USED IN SURGERY; THEREFORE NOT CAUSING ANY IMPACT TO PT OUTCOME. PER RMA, MOTION CONTROLLER BOX WAS REPLACED, PER EVAL OF RETURNED BOX, THE Z AMPLIFIER WAS DEAD.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THE GANTRY OF THE O-ARM DROVE INTO TABLE CAUSING THE Z AXIS TO NO LONGER WORK. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-ARM 1000 IMAGING SYSTEM SYSTEM, XRAY, MOBILE (IZL) IZL MEDTRONIC NAVIGATION, INC. BI-700-00027-120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1