BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE CARDIO

    MDR report key: 22529527 · Received July 17, 2025

    Report

    Report Number
    22529527
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    July 6, 2025
    Report Date
    July 15, 2025
    Manufacturer
    MERGE HEALTHCARE SOLUTIONS INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MERGE WAS TAKING A LONG TIME TO "ZERO" DURING A STEMI [ST-ELEVATION MYOCARDIAL INFARCTION] CASE, AND IT TOOK MULTIPLE ATTEMPTS TO ZERO ARTERIAL LINE, DESPITE TRYING THE TRANSDUCER BEING IN MULTIPLE LOCATIONS. IT DID DELAY PUTTING THE CATHETER IN. RN MOVED THE TRANSDUCER MULTIPLE PLACES AND TRIED FLUSHING/ OPENING CLOSING THE TRANSDUCER IN TROUBLESHOOTING ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615854 MERGE CARDIO SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ MERGE HEALTHCARE SOLUTIONS INC. PB-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female