BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 22113963 · Received May 30, 2025

    Report

    Report Number
    22113963
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 15, 2025
    Report Date
    May 20, 2025
    Manufacturer
    MERGE HEALTHCARE INCORPORATED
    Product Code
    DQK
    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

    CATH LAB ROOM #1 (NEWLY UPDATED PDM [PRODUCT DATA MANAGEMENT] WITH CABLES REPLACED AS OF SPRING) MERGE SYSTEM NOT WORKING: STAFF CHECKED FUNCTION OF ROOM PRIOR TO BRINGING PATIENT IN FOR PROCEDURE. UPON ENTERING WITH PATIENT, ERROR OCCURRED, AND HEMODYNAMIC SCREEN WENT DOWN. TEAM NOTIFIED APPROPRIATE CHANNELS. PROCEDURE HAD NOT STARTED. PDM DISCONNECTED, HEMODYNAMICS SCREEN ON WORKING STATION AND ON MONITORS IN PROCEDURE ROOM WERE BLANK. REBOOTED AT WORKING STATION AND PDM WAS RE-STARTED. SPOKE WITH [REDACTED] FROM MERGE AND [REDACTED] FROM BIOMED CAME IN TO ASSIST. BIOMED WAS ABLE TO GET THE HEMODYNAMICS BACK ON ALL SCREENS. PATIENT WAS ON THE TABLE THROUGHOUT THIS PROCESS, AND THE SYSTEM FAILURE CAUSED A 45 MIN DELAY IN STARTING OUR CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643127 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE INCORPORATED RCSV2

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male