BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO PATIENT DATA MODULE

    MDR report key: 24176997 · Received January 26, 2026

    Report

    Report Number
    24176997
    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

    MERGE HEMODYNAMIC SYSTEM LOST CHANNEL 1 AND CHANNEL 2 ON THE INVASIVE PRESSURES DURING PROCEDURE, NOTIFIED BIOMED AND IT. REBOOTED MERGE AFTER CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65109 MERGE HEMO PATIENT DATA MODULE COMPUTER, DIAGNOSTIC, PROGRAMMABLE, CARDIOVASCULAR DQK MERGE HEALTHCARE INC PB-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male