BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6126432 · Received November 23, 2016

    Report

    Report Number
    1723170-2016-04370
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 23, 2014
    Report Date
    November 23, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE SYSTEM. REPLACEMENT BATTERY CHARGER BOARD #2, HT CONTROLLER, FILAMENT DRIVER, AND 32 BATTERIES WERE SHIPPED TO THE SITE. AFTER REPLACING THE BATTERY CHARGER BOARD #2, HT CONTROLLER, FILAMENT DRIVER, AND 32 BATTERIES, THE MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. THE MEDTRONIC REPRESENTATIVE ALSO PERFORMED A GENERATOR CALIBRATION. SYSTEM PERFORMED AS INTENDED. AN INVESTIGATION WAS COMPLETED AT THE MEDTRONIC FACILITY WHICH CONFIRMED THE REPORTED EVENT WAS CAUSED BY AN ELECTRICAL ISSUE WITH THE BATTERY CHARGER. THE RETURNED BATTERY CHARGER FAILED THE BENCH LEVEL BOARD TEST. THE CHANNEL E OUTPUT WAS ZERO VOLTS FROM NO LOAD TO OVERLOAD. (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 HE WAS UNABLE TO GET THE RAD GAIN CALIBRATION TO PASS FOR THE SYSTEM. HE WAS ABLE TO GET THE FLUORO CALIBRATION TO PASS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775426 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