BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 24648149 · Received March 20, 2026

    Report

    Report Number
    24648149
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 21, 2026
    Report Date
    February 24, 2026
    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

    MERGE HEMO NOT CAPTURING HEART RATE DURING THE PROCEDURE (INAPPROPRIATE VALUES SHOWN AS COMPARED TO ECG WAVEFORM), UNABLE TO CALCULATE AOLVEDP [AORTIC ROOT LEFT VENTRICLE END DIASTOLIC PRESSURE] PRESSURES WHEN NO HR [HEART RATE] AVAILABLE, SPO2 [OXYGEN SATURATION] ALSO NOT MEASURING ACCURATELY. SYSTEM REBOOTED AFTER PROCEDURE WAS COMPLETED IN HOPES TO FIX THE ERROR. LOCATION: CATH LAB #2. DEVICE MODEL # MERGE HEMO 10.3. MANUFACTURER RESPONSE FOR MERGE HEMO MONITORING SYSTEM, MERGE HEMO MONITORING SYSTEM (PER SITE REPORTER). MERGE HEMO HAS A KNOWN ISSUE WHERE IT DOESN'T PICK UP THE HEART RATE ON PATENTS WITH LOW AMPLITUDES OR ELEVATED P-WAVES. HOSPITAL LEADERSHIP IS AWARE OF THIS AND IS IN NEGOTIATION WITH MERGE TO REPLACE OUR EQUIPMENT TO THE MOST CURRENT VERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458165 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE SOLUTIONS INC. 10.3

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other