BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 20063648 · Received August 26, 2024

    Report

    Report Number
    20063648
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 5, 2024
    Report Date
    July 23, 2024
    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

    MERGE HEMODYNAMIC MONITORING SYSTEM DURING CASE SHOWED INACCURATE HEAR RATE (HR) (30'S), PATIENT WAS PLACED ON ANESTHESIA MONITOR HR (70'S). MERGE VENDOR NOTIFIED AND CAME OUT, REPORT TO OUR BIOMED DEPARTMENT, UNABLE TO IDENTIFY CAUSE OF ISSUE; NOTED ROUTINELY OCCURRING. SYSTEM CONTINUES TO PRESENT A RISK AS IT CONTINUES TO FAIL AT DELIVERING ACTUAL PATIENT HEMODYNAMICS, WHICH INCLUDES BUT NOT LIMITED TO RANDOM BLANK OR ZERO SPA)2 LEVELS, RANDOM HR OF 30 OR 0, RANDOM SYSTEM BLANKING OUT DURING MID CASE. THE OEM HAS IN FACT BEEN PRESENT FOR SEVERAL OF THESE OCCURRENCES, HOWEVER HAVE YET TO UNDERSTAND THE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480812 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE INCORPORATED PB-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female