BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JINSHAN PH PROBE

    MDR report key: 23777586 · Received December 11, 2025

    Report

    Report Number
    MW5180316
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Report Date
    December 4, 2025
    Manufacturer
    CHONGQING JINSHAN SCIENCE & TECHNOLOGY (GROUP) CO., LTD.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    OUR LABORATORY HAS ORDERED DIFFERENT PROBES: (B)(6) (PH AVAILABLE 1 PH CHANNEL CATHETER MMS -0Z1P) CALIBRATION IS NOT POSSIBLE FOR PH 4. TIP PLUGS IN BUT CALIBRATION IS NOT POSSIBLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554010 JINSHAN PH PROBE ELECTRODE, PH, STOMACH FFT CHONGQING JINSHAN SCIENCE & TECHNOLOGY (GROUP) CO., LTD. MMS-0Z1P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown