BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIVERSATEK HEALTHCARE

    MDR report key: 20299879 · Received September 25, 2024

    Report

    Report Number
    20299879
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 8, 2024
    Manufacturer
    DIVERSATEK HEALTHCARE, INC.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS HAVING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) AND PLACEMENT OF 24-HOUR IMPEDANCE PH CATHETER. WHEN CALIBRATING THE CATHETER PRIOR TO PLACEMENT, AN IMPEDANCE ERROR MESSAGE APPEARED ON THE RECORDER. TRIED MULTIPLE CATHETERS AND DIFFERENT RECORDERS. ALL HAD THE SAME ERROR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263868 DIVERSATEK HEALTHCARE ELECTRODE, PH, STOMACH FFT DIVERSATEK HEALTHCARE, INC. ZAI-BS-01 004802

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female