BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6096565 · Received November 11, 2016

    Report

    Report Number
    1723170-2016-04188
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    May 8, 2015
    Report Date
    November 11, 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 MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A PLANNED MAINTENANCE (PM), THE FOLLOWING ERRORS WERE OBSERVED: FAILED DOSE VALUE FOR BOOST FLUOROSCOPY; FAILED AIR KIRMA VERIFICATION TEST; FAILED GAIN RAD CALIBRATION. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT. DURING THE ONSITE INSPECTION, THE MEDTRONIC REPRESENTATIVE REPORTED THAT THE MEDTRONIC REPRESENTATIVE PERFORMED THE IMAGING SYSTEM ANNUAL PREVENTIVE MAINTENANCE ACCORDING TO MEDTRONIC PROCEDURES. THE MEDTRONIC REPRESENTATIVE CLEANED, GREASED, AND CORRECTED THE BOOST DOSE-AIR KIRMA-GAIN RAD CALIBRATION. RE-INSTALLED SOFTWARE ON IMAGE ACQUISITION SYSTEM (IAS) COMPUTER DUE TO A SOFTWARE GLITCH THAT APPEARED IN THE GAIN RAD CALIBRATION. INSTALLED MOTION BATTERIES. THE BATTERIES WERE DISCARDED ONSITE. A SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED WHICH VERIFIED THAT THE ISSUE HAD BEEN RESOLVED. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 (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 MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A PLANNED MAINTENANCE (PM), THE FOLLOWING ERRORS WERE OBSERVED: FAILED DOSE VALUE FOR BOOST FLUOROSCOPY; FAILED AIR KIRMA VERIFICATION TEST ; FAILED GAIN RAD CALIBRATION. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747698 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