BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6104725 · Received November 15, 2016

    Report

    Report Number
    1723170-2016-03686
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    April 27, 2015
    Report Date
    November 15, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    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 EQUIPMENT AND WAS ABLE TO REPLICATE THE ISSUE. THE MOBILE VIEW STATION (MVS) INTERFACE CABLE WAS REPLACED, AFTER WHICH THE SYSTEM CHECKOUT WAS SUCCESSFULLY PERFORMED WITH SYSTEM PASSING ALL TESTS. SYSTEM IS PERFORMING AS INTENDED. A MEDTRONIC INVESTIGATION OF THE RETURNED SUSPECT MOBILE VIEW STATION (MVS) INTERFACE CABLE FOUND IT TO HAVE THE LEMO CONNECTOR BENT OUT OF ROUND WITH A CRACK ON THE CONNECTOR HOUSING. THE OUTER INSULATION IS EXHIBITING EXCESSIVE YELLOWING AND IT PASSED CONDUCTIVITY TESTING. HOWEVER, THE BENT LEMO CONNECTOR PREVENTS 100T/GBIT TESTING AND SYSTEM TESTING. (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 CALLED TO REPORT THE THEY WERE HAVING DIFFICULTY CONNECTING THE UMBILICAL CORD TO THE IMAGE ACQUISITION SYSTEM (IAS) AND WAS NOT SURE IF THE CORD ITSELF WAS DAMAGED OR IF THE CONNECTOR ON THE IMAGE ACQUISITION SYSTEM (IAS) WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753247 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