BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6081558 · Received November 7, 2016

    Report

    Report Number
    1723170-2016-04118
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    April 8, 2015
    Report Date
    November 6, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SITE REPRESENTATIVE REPORTED THAT THE FIRST 2D IMAGE APPEARED DARK, MOSTLY BLACK, ON THE MOBILE VIEW STATION (MVS). WHEN THE SECOND IMAGE WAS TAKEN THE IMAGING SYSTEM 'AUTOMATICALLY' COLLIMATED THE 2D IMAGE. AFTER RE-OPENING THE COLLIMATOR CURTAINS, THE KV VALUE WAS ADJUSTED FOR THE SECOND 2D IMAGE AND THE SITE ATTEMPTED TO TAKE THE IMAGE. A WARNING WAS THEN RECEIVED ON THE MVS STATING 'A CABLE WAS LOOSE'. THE EXACT ERROR MESSAGE WAS UNKNOWN. BEFORE TAKING THE THIRD 2D IMAGE, THE SITE 'WIGGLED' THE UMBILICAL CABLE, CHECKED THAT IT WAS CONNECTED SECURELY, AND ADJUSTED THE BRIGHTNESS OF THE IMAGE. THE THIRD 2D IMAGE APPEARED NORMAL. NO ISSUES WERE OBSERVED WITH THE 3D IMAGE. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED. AN ON SITE INSPECTION WAS SCHEDULED FOR A LATER DATE. DURING THE ON SITE INSPECTION, THE UMBILICAL CABLE WAS REPLACED. THE REPLACED CABLE WAS SENT TO THE MANUFACTURER FOR ANALYSIS. A SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED WHICH VERIFIED THAT THE ISSUE HAD BEEN RESOLVED. UPON RECEIVING THE UMBILICAL CABLE, ANALYSIS COULD NOT FIND ANY ISSUE WITH THE PART. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: (B)(6). 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 SITE REPRESENTATIVE REPORTED THAT THE FIRST 2D IMAGE APPEARED DARK, MOSTLY BLACK, ON THE MOBILE VIEW STATION (MVS). WHEN THE SECOND IMAGE WAS TAKEN THE IMAGING SYSTEM 'AUTOMATICALLY' COLLIMATED THE 2D IMAGE. AFTER RE-OPENING THE COLLIMATOR CURTAINS, THE KV VALUE WAS ADJUSTED FOR THE SECOND 2D IMAGE AND THE SITE ATTEMPTED TO TAKE THE IMAGE. A WARNING WAS THEN RECEIVED ON THE MVS STATING 'A CABLE WAS LOOSE'. THE EXACT ERROR MESSAGE WAS UNKNOWN. BEFORE TAKING THE THIRD 2D IMAGE, THE SITE 'WIGGLED' THE UMBILICAL CABLE, CHECKED THAT IT WAS CONNECTED SECURELY, AND ADJUSTED THE BRIGHTNESS OF THE IMAGE. THE THIRD 2D IMAGE APPEARED NORMAL. NO ISSUES WERE OBSERVED WITH THE 3D IMAGE. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED. AN ON SITE INSPECTION WAS SCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735011 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