BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 23257928 · Received October 9, 2025

    Report

    Report Number
    3004513970-2025-00009
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 9, 2025
    Manufacturer
    RESOURCE OPTIMIZATION & INNOVATION, LLC
    Product Code
    DXQ
    PMA / PMN Number
    K921997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERSONNEL WERE SENT TO (B)(6) HOSPITAL TO TALK WITH NICU AND NURSERY STAFF TO BETTER UNDERSTAND THE ISSUE. THIS INVESTIGATION REVEALED THAT MOST INCONSISTENT BLOOD PRESSURE READINGS COULD BE REMEDIED BY GOING UP ONE SIZE ON THE BLOOD PRESSURE CUFF. FOR EXAMPLE, A PATIENT IN THE BPNEO1-REG CUFF WITH HIGH OR INCONSISTENT READINGS WAS MOVED TO THE BPNEO2-REG CUFF AND THE BLOOD PRESSURE READINGS WERE IN THE EXPECTED RANGE. USERS WERE INFORMED AND ADJUSTED THE SIZE OF BLOOD PRESSURE CUFFS USED AND THERE HAVE BEEN NO ADDITIONAL REPORTS OF INCONSISTENT READINGS. ADDITIONALLY, OUR FIRM CREATED A POSTER TO REINFORCE THE TRAINING AND EDUCATION AND MODIFIED FUTURE IMPLEMENTATIONS BY MEETING WITH THE NICU STAFF PRIOR TO CONVERTING THEM TO EXPLAIN DIFFERENCES BETWEEN REGARD CUFFS AND GE OR WELCH ALLYN CUFFS.

    Description of Event or Problem · 0

    BLOOD PRESSURE CUFF READINGS WERE INCONSISTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790531 REGARD DISPOSABLE NEO SOFT CUFF #4 7-13 CM DXQ RESOURCE OPTIMIZATION & INNOVATION, LLC BPNEO4-REG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown