BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6079620 · Received November 4, 2016

    Report

    Report Number
    1723170-2016-03300
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    June 9, 2014
    Report Date
    November 4, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WAS AT THE CUSTOMER'S SITE DURING THE PROCEDURE. THE MEDTRONIC REPRESENTATIVE REPORTED THAT THEY TOOK THE PRE-OPERATIVE SPIN ON THE IMAGE ACQUISITION SYSTEM (IAS). AROUND 30-40 MINUTES LATER, THEY WERE ALIGNING THE IAS TO TAKE 2D SCOUT IMAGES. THEY TOOK AN ANTERIOR / POSTERIOR SCOUT IMAGE. AFTER ROTATING THE IAS TO TAKE A LATERAL IMAGE, THE IAS BECAME UNRESPONSIVE. THE MEDTRONIC REPRESENTATIVE RESTARTED THE APPLICATION ON THE MOBILE VIEW STATION (MVS) AND THE SYSTEM WORKED. THE SOFTWARE FUNCTIONED AS DESIGNED. THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS UNRELATED TO A SOFTWARE ISSUE. THE SOFTWARE INVESTIGATION REVEALED THE ISSUE WAS CAUSED BY A POOR CONNECTION OF THE UMBILICAL CORD. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: (B)(4). 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

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A PROCEDURE, THE LIGHTS ON THE SITE'S IMAGE ACQUISITION SYSTEM (IAS) WERE BLINKING WHILE IT WAS WAITING TO BE USED. THE PENDANT WAS CYCLING ON 2D, LIKE IT WAS REBOOTING ITSELF OVER AND OVER AGAIN. THE MEDTRONIC REPRESENTATIVE REBOOTED THE APPLICATION ON THE MOBILE VIEW STATION (MVS) WHICH RESOLVED THE ISSUE. AFTER REBOOTING THE APPLICATION, THE IAS FUNCTIONED NORMALLY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF AROUND 5 MINUTES DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731306 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 60 YR