BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 21410111 · Received February 19, 2025

    Report

    Report Number
    21410111
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    February 2, 2025
    Report Date
    February 12, 2025
    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

    DURING HEART CATHETERIZATION INSIDE CATH LAB #2, MERGE WAS NOT READING THE PATIENT¿S O2 SATURATION OR END-TIDAL CARBON DIOXIDE (ETCO2). NO HARM OCCURRED TO THE PATIENT. BACKUP HEMODYNAMICS WERE BEING MONITORED VIA ANESTHESIA MONITOR. MANUFACTURER RESPONSE FOR COMPUTER, DIAGNOSTIC, PROGRAMMABLE, MERGE HEMO (PER SITE REPORTER). ONGOING MERGE SOFTWARE ISSUES, VENDOR IN PROCESS OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2540101 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE INCORPORATED PB-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male