BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM

    MDR report key: 20190516 · Received September 11, 2024

    Report

    Report Number
    2124215-2024-56511
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    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

    D2B: PRO CODE (PRODUCT CODE): DQK, DSK, IYO, ITX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE POWER CORD ISSUE OCCURRED. AN AVVIGO PLUS MULTI-MODALITY GUIDANCE SYSTEM WAS INSTALLED, AND IT WAS NOTED THAT THE POWER CABLE AND HARNESS WERE SECURED, AND THE SYSTEM PASSED ALL FUNCTIONAL TESTING. THE WIRES OF THE AVVIGO PLUS POWER CORD WERE NOT SECURED AND SPARKING. IT WAS DISCOVERED THAT DAYS AFTER THE INSTALL, THE USER HAD MOVED THE TABLE SIDE CONTROLLER (TSC) DISPLAY FROM ITS ORIGINAL LOCATION. THE BOSTON SCIENTIFIC FIELD SERVICES RESPONDED, THE POWER CORD CONNECTOR WAS REPLACED, AND ALL CABLES WERE REROUTED AND SECURED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020510 AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE, COMPUTER, BLOOD-PRESSURE DQK BOSTON SCIENTIFIC CORPORATION 0104733855

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown