BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDI PASSIVE SPHERES

    MDR report key: 5087741 · Received September 18, 2015

    Report

    Report Number
    3002743211-2015-00051
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 20, 2015
    Manufacturer
    NORTHERN DIGITAL INC.
    Product Code
    HAW
    PMA / PMN Number
    K033621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED BY SITE.

    Description of Event or Problem · 1

    THIS EVENT WAS COMMUNICATED BY A MEDTRONIC (B)(4) REPRESENTATIVE FROM HOSPITAL (B)(6). IN STERILE FIELD, THE DEVICE (SPHERES) WAS NOT RECOGNIZED. SO, THE TEAM CHANGED THE SPHERES AND EVERYTHING WORKED WELL. COMPLAINANT NOTED THAT THIS ISSUE DID NOT INVOLVE A PATIENT. THEREFORE NO SERIOUS INJURY OR ADVERSE EVENT TO A PATIENT. DEVICE WAS NOT RETURNED. EXCEPT WHEN ROTATED. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620025 NDI PASSIVE SPHERES REFLECTIVE PASSIVE MARKER SPHERES HAW NORTHERN DIGITAL INC. 8801075

    Patients

    Seq Age Sex Outcome Treatment
    1