BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6083940 · Received November 7, 2016

    Report

    Report Number
    1723170-2016-03311
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    November 17, 2015
    Report Date
    November 7, 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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A REPLACEMENT POWER SWITCHING BOARD, SYSTEM CONTROL BOARD ASSEMBLY, AND A COMPUTER WERE SHIPPED TO THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO REPLACE THE PARTS. AFTER THE POWER SWITCHING BOARD, SYSTEM CONTROL BOARD ASSEMBLY, AND THE COMPUTER WERE REPLACED, THE MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. INVESTIGATION OF RETURNED SUSPECT POWER SWITCHING BOARD WAS UNABLE TO CONFIRM THE REPORTED ISSUE "SYSTEM BOOTING PLEASE WAIT". THE POWER SWITCHING BOARD WAS INSTALLED IN THE IMAGE ACQUISITION SYSTEM (IAS) 267 WHERE IT FUNCTIONED AS EXPECTED. THE IAS STARTED UP WITHOUT ERROR AND THE SYSTEM REMAINED READY. NO PROBLEM WAS FOUND. INVESTIGATION OF RETURNED SUSPECT SYSTEM CONTROL BOARD WAS UNABLE TO CONFIRM THE REPORTED ISSUE "SYSTEM BOOTING PLEASE WAIT". THE SYSTEM CONTROL BOARD WAS INSTALLED IN THE IMAGE ACQUISITION SYSTEM (IAS) 267 WHERE IT FUNCTIONED AS EXPECTED. THE IAS STARTED UP WITHOUT ERROR AND THE SYSTEM REMAINED READY. NO PROBLEM WAS FOUND. INVESTIGATION OF RETURNED SUSPECT COMPUTER WAS UNABLE TO CONFIRM THE REPORTED ISSUE "SYSTEM BOOTING PLEASE WAIT". THE IMAGE ACQUISITION SYSTEM (IAS) COMPUTER FUNCTIONED AS EXPECTED DURING BENCH TESTING. THE VIRUS SCAN AND CMOS/BIOS CHECKS WERE GOOD. THE COMPUTER WAS INSTALLED IN THE IMAGE ACQUISITION SYSTEM (IAS) 116R AND IT OPERATED AS EXPECTED WITH NO INITIALIZATION FAILURES. NO PROBLEM WAS FOUND. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) OFFICE ON (B)(6) 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO (B)(6) 2016 (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 (B)(4) 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 (B)(6)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 WHILE ONSITE PERFORMING A SYSTEM CHECKOUT ON THE IMAGE ACQUISITION SYSTEM (IAS), HE DISCOVERED THE IAS WOULD NOT COMPLETELY BOOT UP AND THE PENDANT DISPLAYED "SYSTEM BOOTING, PLEASE WAIT". THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734476 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