BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPAL HDX

    MDR report key: 23581092 · Received November 18, 2025

    Report

    Report Number
    2124215-2025-83900
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    00191506055370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    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 THE ISOLATION TRANSFORMER PACKAGED WITH THE OPAL HDX MAPPING SYSTEM INSTALL BUNDLE WAS MISLABELED AS THE UNITED STATES MODEL BUT WAS ACTUALLY THE EUROPEAN MODEL. THIS WAS AN OUT-OF-BOX FAILURE, SO NO PATIENT WAS INVOLVED. A REPLACEMENT TRANSFORMER WAS SHIPPED TO THE CUSTOMER AND INSTALLED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446054 OPAL HDX COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION M004OPLINSTALL2EN0 1000001976 00191506055370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown