BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6068461 · Received October 31, 2016

    Report

    Report Number
    1723170-2016-04690
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    January 8, 2016
    Report Date
    October 31, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. THE SITE REPORTED THAT, OUTSIDE OF SURGERY, THERE WAS NO CONNECTION ESTABLISHED BETWEEN THE MOBILE VIEW STATION (MVS) AND THE IMAGE ACQUISITION SYSTEM (IAS). THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. UPON ONSITE INVESTIGATION, THE MOBILE VIEW STATION (MVS) UMBILICAL CABLE WAS RETURNED AND REPLACED, ALSO, THE ONSITE TECH REINSTALLED THE SOFTWARE WHICH RESOLVED THE ISSUE. NO OTHER ISSUES WERE REPORTED. UPON ANALYSIS OF THE RETURNED CABLE, NO FAULTS WERE FOUND AS IT FUNCTIONED AS DESIGNED. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. THIS REVIEW WAS PERFORMED AS A RESULT OF RECENT CHANGES/IMPROVEMENTS TO THE MEDTRONIC NAVIGATION, INC. MEDICAL DEVICE REPORT (MDR) REVIEW PROCESS AND IS FOR NON-ADVERSE EVENT REPORTABLE MALFUNCTIONS WITHIN THE LAST TWO YEARS WHERE THE REPORTED MALFUNCTION WAS NOT PREVIOUSLY ASSOCIATED WITH SERIOUS INJURIES. SIMILAR MALFUNCTIONS THAT HAD RESULTED IN SIGNIFICANT DELAYS OF SURGERY OR REQUIRED ADDITIONAL INTERVENTION HAD BEEN REPORTED AS MDR SERIOUS INJURIES. BASED ON THIS 483 OBSERVATION, THE REPORTING DETERMINATION HAS BEEN REVISED TO CONSIDER THESE MALFUNCTION EVENTS REPORTABLE. THIS PROCESS CHANGE RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY MEDTRONIC NAVIGATION, INC., SINCE APRIL 2016. IT SHOULD BE NOTED THAT THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION AND APPLICATION OF THE REGULATIONS WITHIN OUR PROCESSES.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT, OUTSIDE OF SURGERY, THERE WAS NO CONNECTION ESTABLISHED BETWEEN THE MOBILE VIEW STATION (MVS) AND THE IMAGE ACQUISITION SYSTEM (IAS). THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718274 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1