BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 22529570 · Received July 17, 2025

    Report

    Report Number
    22529570
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    July 4, 2025
    Report Date
    July 15, 2025
    Manufacturer
    MERGE HEALTHCARE SOLUTIONS 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(B)(6)- NEW MERGE PDM [PATIENT DATA MODULE] #(B)(6): DURING PACEMAKER INSERTION THERE WAS MULTIPLE REPOSITIONING OF RV [RIGHT VENTRICLE] LEAD. PATIENT HAD A BLOOD PRESSURE CUFF READING IN 50'S SYSTOLIC. AFTER A SECOND CUFF READING OF 60'S SYSTOLIC, MERGE VITALS SCREEN COMPLETELY SHUT DOWN AND WAS SHOWING A BLACK SCREEN WITH THE ERROR MESSAGE "PDM DISCONNECTED". AT THAT TIME, IT WAS ASSUMED PATIENT WAS EXPERIENCING A CARDIAC TAMPONADE. RN WENT TO GET ANOTHER PORTABLE VITALS MACHINE. ANOTHER NURSE WAS TROUBLESHOOTING MERGE. WAS ABLE TO GET MERGE BACK UP AFTER A SHUTDOWN OF THE MONITOR AND PDM. IT WAS DOWN APPROXIMATELY 15-20 MINUTES WHILE PATIENT WAS DETERIORATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821645 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE SOLUTIONS INC. MERGE HEMO PDM

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male