BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z800WF

    MDR report key: 24148196 · Received January 22, 2026

    Report

    Report Number
    3006575795-2026-00901
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 26, 2025
    Report Date
    January 22, 2026
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF INTUVIE¿S SERVICE RECORDS WAS DONE AND NO PRIOR SERVICE EVENTS DOCUMENTING THE SAME FAILURE MODE WERE IDENTIFIED FOR THIS DEVICE. COMPLAINT HISTORY WAS ALSO REVIEWED, AND NO PREVIOUS COMPLAINTS ASSOCIATED WITH THE SAME FAILURE WERE IDENTIFIED. THE 30 PSI OCCLUSION FAILURE IDENTIFIED DURING SERVICE WAS CONFIRMED DURING TESTING. THIS FAILURE MODE IS BEING EVALUATED UNDER CAPA-15, ¿OCCLUSION SENSOR PM COMPLAINT TRENDS.¿ TO CORRECT THE ISSUE, THE 30 PSI CALIBRATION VALUE WAS ADJUSTED FROM 237 TO 260, AFTER WHICH THE DEVICE MET APPLICABLE PERFORMANCE SPECIFICATIONS. PROBABLE CAUSE IS THE DEVICE BEING OUT OF CALIBRATION. REFER TO COMPLAINT RECORD (B)(4) FOR ADDITIONAL DETAILS.

    Description of Event or Problem · 0

    (B)(6) WAS SERVICED BY MED-TECH SUPPORT SERVICES, INC., DURING WHICH THE DEVICE FAILED THE 30 PSI OCCLUSION TEST. AS PART OF THEIR SERVICE EVALUATION, MED-TECH SUPPORT SERVICES, INC. REPLACED THE PRESSURE SENSOR IN AN ATTEMPT TO CORRECT THE ISSUE; HOWEVER, THE DEVICE CONTINUED TO FAIL 30 PSI OCCLUSION TESTING. FOLLOWING UNSUCCESSFUL CORRECTION AT THE SERVICE PROVIDER, THE PUMP WAS SENT TO INTUVIE FOR FURTHER EVALUATION AND SERVICING TO ADDRESS THE IDENTIFIED FAILURE. NO PATIENT INVOLVEMENT OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211785 Z800WF PUMP, INFUSION FRN ZYNO MEDICAL, LLC Z-800WF IV INFUSION PUMP 240119368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown