BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTOMONITOR 3

    MDR report key: 19153460 · Received April 19, 2024

    Report

    Report Number
    MW5154051
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    February 29, 2024
    Report Date
    April 18, 2024
    Manufacturer
    OPSENS INC.
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT CARDIAC CATHETERIZATION ON (B)(6) 2024, DURING PROCEDURE THE BOX THAT SHOWS PERCENTAGES OF ESTIMATED HEART BLOCK STOPPED COMMUNICATING. DELAYED CASE FOR APPROXIMATELY 10 MINUTES WHILE TROUBLESHOOTING. '' REF-F2330, (B)(6)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190189 OPTOMONITOR 3 TRANSDUCER, PRESSURE, CATHETER TIP DXO OPSENS INC. F2310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown