BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5989294 · Received September 29, 2016

    Report

    Report Number
    1723170-2016-03460
    Event Type
    Malfunction
    Date Received
    September 29, 2016
    Date of Event
    February 3, 2015
    Report Date
    September 29, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS WERE RECEIVED BY THE MANUFACTURER. ON 19-FEB-2016, AN ON-SITE FUNCTIONAL INVESTIGATION WAS COMPLETED. THE IMAGING SYSTEM FUNCTIONED PROPERLY UPON REPLACING THE GANTRY HOME POSITION SENSOR WITH THE WAG OPTICAL SENSOR. NO FURTHER ISSUES WERE REPORTED. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 (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 THE DOOR OF THE IMAGING SYSTEM COULD NOT BE OPENED. HOSPITAL PERSONNEL TRIED TO OPEN THE DOOR MANUALLY BUT DID NOT FOLLOW THE CORRECT PROCEDURE, FORCING THE OPENING BOLT, WHICH CAUSED THE PLASTIC GUIDES TO BEND AND THE BOLT TO BREAK, DAMAGING THE DOOR WINCH ASSEMBLY. DURING TROUBLE-SHOOTING, THE DOOR WINCH ASSEMBLY WAS REPLACED, BUT THIS DID NOT RESOLVE THE ISSUE. THE SYSTEM RETURNED TO ITS NORMAL OPERATIONAL STATE AFTER REPLACING THE GANTRY MOTION CONTROLLER AND HOME POSITION SENSOR. 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
    637712 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