BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BP-200 PLUS

    MDR report key: 23532400 · Received November 12, 2025

    Report

    Report Number
    8030978-2025-86836
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 29, 2025
    Manufacturer
    SCHILLER AG
    Product Code
    DXN
    UDI-DI
    07613365000122
    PMA / PMN Number
    K063814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER IN JORDAN INFORMED SCHILLER AG THAT THE DEVICE DISPLAYED FAULTY BLOOD PRESSURE READINGS WHICH ARE TOO HIGH. THE PATIENT DID THE TEST ON ANOTHER DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER IN JORDAN INFORMED SCHILLER AG THAT THE DEVICE DISPLAYED FAULTY BLOOD PRESSURE READINGS WHICH ARE TOO HIGH. THE PATIENT DID THE TEST ON ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403851 BP-200 PLUS BP-200 PLUS DXN SCHILLER AG 3.930300 07613365000122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other