BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6095997 · Received November 11, 2016

    Report

    Report Number
    1723170-2016-03928
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    September 30, 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
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) WOULD SPORADICALLY SHOW A "GENERATOR OVERLOAD FAULT." THEY NOTED THAT THE SYSTEM HAD SEVERAL PARTS REPLACED, AND HAD BEEN SENT BACK TO MANUFACTURER FOR REPAIR AS WELL BUT FAULT KEPT OCCURRING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. ONSITE INVESTIGATION COULD NOT REPRODUCE THE REPORTED EVENT, THEREFORE, NO FINDINGS WERE POSSIBLE. FURTHER UPDATES WERE RECEIVED THAT THE ISSUE HAD NOT RECURRED AND THAT THEY WERE STILL PLANNING ON REPLACING THE HV TANK PER MANUFACTURER RECOMMENDATION. PART WILL BE ORDERED THROUGH LOCAL DEPOT AND SYSTEM IS CURRENTLY FUNCTIONAL. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: (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 MEDTRONIC REPRESENTATIVE REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) WOULD SPORADICALLY SHOW A "GENERATOR OVERLOAD FAULT." THEY NOTED THAT THE SYSTEM HAD SEVERAL PARTS REPLACED, AND HAD BEEN SENT BACK TO MANUFACTURER FOR REPAIR AS WELL BUT FAULT KEPT OCCURRING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746654 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