BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO PATIENT DATA MODULE

    MDR report key: 24177195 · Received January 26, 2026

    Report

    Report Number
    24177195
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 9, 2026
    Report Date
    January 13, 2026
    Manufacturer
    MERGE HEALTHCARE, INC.
    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 4 CLIENT MERGE SYSTEM LOST CONNECTIVITY. STAFF REPORT SCREEN FREEZING AND UNABLE TO DOCUMENT THE CASE. STAFF REBOOTED THE SYSTEM AND CONTINUED PROCEDURE. LOST CONNECTIVITY AGAIN. PATIENT DOCUMENTATION FREEZING. ABLE TO REBOOT MERGE AND CONTINUE. BIOMED AND IT IN CONTROL ROOM WAITING TO ASSIST AND WILL EVALUATE AS SOON AS PROCEDURE ENDS. STAFF AND MD FEEL ROOM UNSTABLE TO CONTINUE UNTIL THIS ISSUE IS FIXED. WE WILL CHECK TO SEE IF THE INFORMATION FLOWS OVER TO CATH LAB REPORT IN CERNER AFTER THE CASE ENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610308 MERGE HEMO PATIENT DATA MODULE COMPUTER, DIAGNOSTIC, PROGRAMMABLE, CARDIOVASCULAR DQK MERGE HEALTHCARE, INC. PB-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female