BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMAP?

    MDR report key: 24068465 · Received January 14, 2026

    Report

    Report Number
    2124215-2026-02430
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 16, 2025
    Report Date
    May 13, 2026
    Manufacturer
    CORTEX INC.
    Product Code
    DQK
    UDI-DI
    00850064686005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: FOLLOWING RECEIPT AND INSPECTION OF THE RETURNED DEVICE, NO EXTERNAL ABNORMALITIES WERE OBSERVED. THE DEVICE PASSED ALL TESTS PERFORMED, AND NO EVIDENCE OF THE REPORTED FAILURE WAS IDENTIFIED. THE UNIT WAS RETURNED TO THE HOSPITAL, WHERE THE ISSUE ALSO COULD NOT BE REPRODUCED. DEVICE HISTORY REVIEW: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: BOSTON SCIENTIFIC ASSIGNED THE INVESTIGATION CONCLUSION CODE NO PROBLEM DETECTED. THE RETURNED OPTI-AMP WAS EVALUATED, AND THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE UNIT WAS ALSO EVALUATED AT THE HOSPITAL, WHERE THE ISSUE COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SYSTEM INSTALLATION FOR A STUDY PROCEDURE, HOSPITAL BIOMEDICAL ENGINEERING ELECTRICAL SAFETY TESTING WAS PERFORMED, AND THE AC GROUND RESISTANCE FOR THE OPTI-AMP AMPLIFIER WAS TOO HIGH (0.96 TO 3.49 OHMS). HOSPITAL SPECIFICATION IS LESS THAN 0.5 OHMS. MULTIPLE TESTERS AND POWER CABLES WERE USED. THERE WAS NO ERROR MESSAGES ASSOCIATED WITH THE AMPLIFIER AS IT FAILED DURING BIOMEDICAL ELECTRICAL TESTING AND WAS NOT CONNECTED TO THE SYSTEM AT THAT TIME. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SYSTEM INSTALLATION FOR A STUDY PROCEDURE, HOSPITAL BIOMEDICAL ENGINEERING ELECTRICAL SAFETY TESTING WAS PERFORMED, AND THE AC GROUND RESISTANCE FOR THE OPTI-AMP AMPLIFIER WAS TOO HIGH (0.96 TO 3.49 OHMS). HOSPITAL SPECIFICATION IS LESS THAN 0.5 OHMS. MULTIPLE TESTERS AND POWER CABLES WERE USED. THERE WAS NO ERROR MESSAGES ASSOCIATED WITH THE AMPLIFIER AS IT FAILED DURING BIOMEDICAL ELECTRICAL TESTING AND WAS NOT CONNECTED TO THE SYSTEM AT THAT TIME. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311221 OPTIMAP? COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK CORTEX INC. OPTI-AMP 00850064686005

    Patients

    Seq Age Sex Outcome Treatment
    1