BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURONAV

    MDR report key: 17161253 · Received June 20, 2023

    Report

    Report Number
    3001610756-2023-00001
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    September 21, 2022
    Report Date
    June 20, 2023
    Manufacturer
    ALPHA OMEGA ENGINEERING LTD.
    Product Code
    GZL
    UDI-DI
    07290014954052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NEURONAV "SYSTEM" SN (B)(6) WAS SUPPLIED TO THE (B)(6) HOSPITAL IN 2017, IT LEFT ALPHA OMEGA'S FACILITY ON AUGUST 14TH 2017. THIS SYSTEM LAST PASSED PREVENTIVE "MAINTENANCE" ON OCTOBER 18TH 2021 BEFORE THIS MALFUNCTION, PRIOR TO THAT IT PASSED PREVENTIVE "MAINTENANCE" EACH YEAR. FOLLOWING THIS MALFUNCTION, THIS NEURONAV MAIN UNIT WAS REPAIRED AND UPGRADED TO HIGHER DEVICE VERSION AT ALPHA OMEGA FACILITY, AND SHIPPED BACK TO USA ON DEC 20, 2022. THE SYSTEM WAS SHIPPED BACK TO THE HOSPITAL ON JAN 31, 2023. FOLLOWING "RECEIVING" THE UNIT, THE HOSPITAL "RECEIVED" CASE SUPPORT ON APRIL 17TH 2023 BY ALPHA OMEGA REPRESENTATIVE, AND REPORTED "SUCCESSFUL" PROCEDURE.

    Description of Event or Problem · 0

    THE NEURONAV HDD LAPTOP FAILED, SO THE SYSTEM LAPTOP FAILED TO BOOT, AN ALTERNATIVE NEUROSMART SYSTEM FROM ANOTHER HOSPITAL WAS BORROWED, SO THE HOSPITAL PROCEEDED WITH THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662202 NEURONAV LNTRAOPERATIVE NEUROPHYSIOLOGICAL RECORDING AND STIMULATING DEVICE GZL ALPHA OMEGA ENGINEERING LTD. 14 07290014954052

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female