BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6102947 · Received November 15, 2016

    Report

    Report Number
    1723170-2016-04648
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    January 7, 2015
    Report Date
    November 15, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A SITE REPRESENTATIVE REPORTED THAT THERE WAS AN IMAGING SYSTEM BOOT ERROR AND THAT THE MOBILE VIEW STATION (MVS) WOULD NOT GET PAST THE BOOTING PHASE. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT. AN ONSITE INSPECTION WAS SCHEDULED FOR A LATER DATE.DURING THE ONSITE INSPECTION, THE MEDTRONIC REPRESENTATIVE REPORTED THAT THE UMBILICAL CABLE, THE IMAGING SYSTEM COMPUTER, THE COLLIMATOR, AND THE ROTOR MOTION CONTROL BOX WERE REPLACED. THE REPLACED PARTS WAS SENT TO THE MANUFACTURER FOR PART ANALYSIS. A SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED WHICH VERIFIED THAT THE ISSUE HAD BEEN RESOLVED. DURING PART ANALYSIS THERE WAS A CONFIRMED SOFTWARE AND ELECTRICAL FAILURE WITH THE IMAGING SYSTEM COMPUTER AND ROTOR MOTION CONTROL BOX, RESPECTIVELY. 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

    A SITE REPRESENTATIVE REPORTED THAT THERE WAS AN IMAGING SYSTEM BOOT ERROR AND THAT THE MOBILE VIEW STATION (MVS) WOULD NOT GET PAST THE BOOTING PHASE. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT. AN ONSITE INSPECTION WAS SCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754926 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