BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIVERSATEK HEALTHCARE

    MDR report key: 25027501 · Received April 29, 2026

    Report

    Report Number
    25027501
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 20, 2026
    Manufacturer
    DIVERSATEK HEALTHCARE, INC.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    24 HR PH PROBE WOULD NOT CALIBRATE, CHECKED ALL CONNECTIONS, THEN RETRIED CALIBRATION, STILL WOULD NOT CALIBRATE, THEN CHANGED PH SOLUTIONS AGAIN AND THEN TRIED AGAIN, STILL WOULD NOT CALIBRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096625 DIVERSATEK HEALTHCARE ELECTRODE, PH, STOMACH FFT DIVERSATEK HEALTHCARE, INC. PHN15 005588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other