BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6101165 · Received November 14, 2016

    Report

    Report Number
    1723170-2016-03524
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    May 18, 2015
    Report Date
    November 14, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS EVENT. NO PARTS WERE RECEIVED BY MANUFACTURER. EVENT PROBLEM AND EVALUATION: ON 14 -JUL-2015, A MEDTRONIC REPRESENTATIVE, FOLLOWING UP WITH THE SITE, REPORTED THAT THE SITE REPLACED THE BATTERIES WITH BATTERIES THEY HAD ORDERED. THE GANTRY ISSUE WAS RESOLVED DURING AN IMAGING SYSTEM CHECKOUT (COMPLETED ON (B)(6) 2015), BUT NO ROOT CAUSE WAS IDENTIFIED. (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 SITE REPRESENTATIVE REPORTED THAT IMAGING SYSTEMS MOTION AND X-RAY BATTERIES WERE NOT HOLDING CHARGE. THEY WOULD GET ABOUT 10 MINUTES OF DRIVE TIME WITH THE SYSTEM BEFORE IT WOULD POWER OFF. THEY WERE ALSO RECEIVING A CRITICAL BATTERY LEVEL ERROR MESSAGE ON THE MOBILE VIEW STATION (MVS). THEY CONFIRMED THAT THE SYSTEM WAS PLUGGED IN AND CHARGING OVERNIGHT WHEN NOT IN USE. IT WAS ALSO REPORTED THAT THE SYSTEMS GANTRY WOULD ONLY EXTEND OUTWARD 4-5 INCHES AND THEN STOP. ALL OTHER GANTRY MOTIONS (WAG, TILT, UP AND DOWN (Y-DIRECTION)) WERE FUNCTIONING AS EXPECTED. NO PATIENT WAS PRESENT WHEN THIS EVENT OCCURRED, SO NO PATIENT DEMOGRAPHICS ARE APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750708 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