BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 25063794 · Received May 3, 2026

    Report

    Report Number
    1417592-2026-00780
    Event Type
    Malfunction
    Date Received
    May 3, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    DXN
    UDI-DI
    00888277675714
    PMA / PMN Number
    K193627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER REPORT, " CUSTOMER BLOOD PRESSURE MONITOR GIVING ERROR OF U. TRIED REPLACING BATTERIES AND STILL NOT WORKING. SHE STATED SHE TRIED IT ON SEVERAL FAMILY MEMEBERS AND UNIT DISPLAYS THE ERROR. WOULD LIKE A REPLACEMENT." THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PER REPORT, " CUSTOMER BLOOD PRESSURE MONITOR GIVING ERROR OF U. TRIED REPLACING BATTERIES AND STILL NOT WORKING. SHE STATED SHE TRIED IT ON SEVERAL FAMILY MEMEBERS AND UNIT DISPLAYS THE ERROR. WOULD LIKE A REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307927 MEDLINE DBD-MONITOR,BP,AUTO,DIGITAL,UNIVERSAL DXN MEDLINE INDUSTRIES, LP 228027046 00888277675714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown