BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM VITAL¿ CONSOLE

    MDR report key: 22159456 · Received June 6, 2025

    Report

    Report Number
    1045254-2025-01472
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 2, 2025
    Report Date
    July 30, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000395896
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOUND THAT THE MUTING DETECTOR JACK WAS BROKEN. H6: FDR C070603 AND IMG G02017 CODES ARE APPLICABLE. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4); H3: PRODUCT ANALYSIS FOUND THAT THE DEVICE RECEIVED WITH SOFTWARE REV 1.7.5 INSTALLED. RADIO FIRMWARE REVISION WAS NOT CORRECT. H6: FDR C10 AND IMG G02008 CODES ARE APPLICABLE. PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4) H3: PRODUCT ANALYSIS FOUND THAT SCREW HOLE BOSSES, SHROUD, USB-C CONNECTOR WERE BROKEN. H6: FDR C070603, IMG G0405213, IMG G04070 AND IMG G04034 CODES ARE APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H6: INITIALLY SUBMITTED CODE FDC D16 IS NO LONGER APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRE-OP, THE CONSOLE TOOK A LONG TIME TO BOOT UP, THERE WERE INTERMITTENT CONNECTION ISSUES WITH THE WIRED CABLE CONNECTION AND PATIENT INTERFACE BOXES. MUTING ADAPTER SEEMS LOOSE, SYSTEM MAKES NOISE WHEN USING CAUTERY. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493548 NIM VITAL¿ CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 225206915 00763000395896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11....".