BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGUS PB-3000

    MDR report key: 22779647 · Received August 11, 2025

    Report

    Report Number
    2183926-2025-00017
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 11, 2025
    Manufacturer
    SCHILLER AG (BAAR, SWITZERLAND)
    Product Code
    MHX
    UDI-DI
    07613365004359
    PMA / PMN Number
    K233326
    Removal / Correction Number
    TO BE PROVIDED IN FOLLOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SCHILLER AG PROVIDED MERGE HEALTHCARE INC. WITH A LIST OF ALL AFFECTED ARGUS PB-3000 SERIAL NUMBERS. MERGE PERFORMED AN INVESTIGATION TO IDENTIFY ALL AFFECTED MERGE HEMO, MODEL RCSV2 SYSTEMS, AND CREATED A CONSIGNEE LIST. MERGE FIELD SERVICE ENGINEERS WILL BE GOING ONSITE TO TEST THE 27 LIVE UNITS AND WILL TEST THE 57 UNITS SHIPPED BUT PENDING INSTALL AT TIME INSTALLATION. ALL DEFECTIVE PB-3000S WILL BE RETURNED TO SCHILLER AG.

    Description of Event or Problem · 0

    DURING MERGE HEALTHCARE INCORPORATED (HARTLAND, WI) INTERNAL TESTING OF THE MERGE HEMO, MODEL RCSV2 SYSTEM, IT WAS OBSERVED THAT CERTAIN SCHILLER AG ARGUS PB-3000 PATIENT DATA MODULE (PDM) UNITS TRIGGERED AN ERROR MESSAGE (ERROR CODE: PRESSURE SENSOR DEFECTIVE) WHEN PERFORMING NON-INVASIVE BLOOD PRESSURE (NIBP) MEASUREMENTS WITH AN INITIAL PRESSURE OVER 240 MMHG. THE PROBLEM WAS FURTHER INVESTIGATED AND CONFIRMED BY SCHILLER AG (BAAR, SWITZERLAND), THE ORIGINAL EQUIPMENT MANUFACTURER FOR THE PB-3000. THE SCHILLER AG (BAAR, SWITZERLAND) ARGUS PB-3000 PATIENT DATA MODULE (PDM) IS A VITAL SIGNS MONITORING DEVICE INTENDED TO BE INTEGRATED INTO MERGE HEALTHCARE INCORPORATED'S (HARTLAND, WI) MERGE HEMO, MODEL RCSV2 SYSTEM. MERGE HEALTHCARE INCORPORATED (900 WALNUT RIDGE DRIVE, HARTLAND, WI, 53029 USA; FEI: 1000116130) IS THE INITIAL IMPORTER OF THE ARGUS PB-3000 PDM. NO OTHER COMPONENTS OF THE MERGE HEMO, MODEL RCSV2 SYSTEM ARE AFFECTED. SCHILLER AG (BAAR, SWITZERLAND) HAS DETERMINED THAT WHEN THE INFLATION PRESSURE IS IN THE HIGH-PRESSURE RANGE (>240 MMHG), THE NON-INVASIVE BLOOD PRESSURE (NIBP) MIGHT BECOME NON-FUNCTIONAL. THIS MAY LEAD TO A SHORT DELAY IN DELIVERY OF CARE THAT COULD HAVE MINOR HEALTH IMPACT. SCHILLER AG (BAAR, SWITZERLAND) HAS DETERMINED THE ROOT CAUSE OF THE ISSUE TO BE AN IMPROPER ADJUSTMENT OF THE SECONDARY PRESSURE SENSOR DURING MANUFACTURING OF THE ARGUS PB-3000 PATIENT DATA MODULE (PDM). THIS FAULTY ADJUSTMENT MAY RESULT IN A MEASUREMENT ERROR BEING DETECTED BY THE PDM DEVICE, LEADING TO THE OBSERVED ERROR MESSAGE ON THE HOST SYSTEM (MERGE HEMO, MODEL RCSV2 SYSTEM) HEMO CLIENT APPLICATION SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363943 ARGUS PB-3000 ARGUS PB-3000 PATIENT DATA MODULE (PDM) MHX SCHILLER AG (BAAR, SWITZERLAND) 3.921033 07613365004359

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown