BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

    MDR report key: 8174468 · Received December 18, 2018

    Report

    Report Number
    3004785967-2018-00640
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 11, 2018
    Report Date
    January 10, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: (B)(4). ACTION/RESOLUTION: THIS UNIT HAD BEEN RUN INTO A DOOR FRAME OR WALL, WITH SIGNIFICANT FORCE. A THROUGHOUT INSPECTION OF THE GANTRY, DOOR, AND COVER WAS PERFORMED. ALL SWITCHES WORK IAW MANUFACTURER SPEC, ISSUES OF NOTED SWITCH 5 NEEDED TO ADJUSTED TO THE RIGHT (FURTHER TO THE RIGHT). AFTER CORRECTIVE ACTION I RECHECKED, AND WAS ABLE TO CLOSE THE DOOR TO THE GANTRY IAW MANUFACTURER SPEC. I REPLACED THE COVERS AND CHECKED AGAIN. NO ISSUES NOTED WITH REPAIR AT THIS TIME UNIT IN GOOD WORKING ORDER. FULL SYSTEM CHECKOUT COMPLETED AFTER REPAIR WITH NO ISSUES TO REPORT. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT HIS UNIT HAD BEEN RUN INTO A DOOR FRAME OR WALL, WITH SIGNIFICANT FORCE. A THROUGHOUT INSPECTION OF THE GANTRY, DOOR, AND COVER WAS PERFORMED ALL SWITCHES WORK IAW MANUFACTURER SPEC, ISSUES OF NOTED SWITCH 5 NEEDED TO ADJUSTED TO THE RIGHT (FURTHER TO THE RIGHT). AFTER CORRECTIVE ACTION I RECHECKED, AND WAS ABLE TO CLOSE THE DOOR TO THE GANTRY IAW MANUFACTURER SPEC. I REPLACED THE COVERS AND CHECKED AGAIN. NO ISSUES NOTED WITH REPAIR AT THIS TIME UNIT IN GOOD WORKING ORDER. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROVIDER (HCP) REGARDING AN IMAGING SYSTEM OUTSIDE OF A PROCEDURE. THE HCP REPORTED THE SYSTEM WAS RUN INTO A WALL, THE COVERS WERE DAMAGED AND THE PENDANT INDICATED THAT THE DOOR WAS OPEN WHEN THE SYSTEM WAS CLOSED. NO PATIENT WAS INVOLVED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014075 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1