BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-800F

    MDR report key: 24747338 · Received March 31, 2026

    Report

    Report Number
    3006575795-2026-01057
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 31, 2026
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILURE MODE WAS CONFIRMED AT MCKESSON. A REVIEW OF THE DEVICE¿S SERIAL NUMBER HISTORY DID NOT IDENTIFY SIMILAR COMPLAINTS. THE PROBABLE CAUSE WAS DETERMINED TO BE A CALIBRATION ISSUE. THE HEX FILE WAS INSTALLED AND THE PUMP 30PSI WAS RECALIBRATED FROM VALUE 223-186. FOLLOWING THESE ACTIONS, THE PUMP SUCCESSFULLY PASSED ALL REQUIRED TESTS. CAPA-15 WAS INITIATED TO INVESTIGATE THE ROOT CAUSE FOR THIS FAILURE MODE. THE OCCLUSION FAILURE WAS IDENTIFIED DURING SERVICING PERFORMED BY A THIRD-PARTY SERVICE PROVIDER. REFERENCE TO COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    INTUVIE RECEIVED A REPORT FROM MCKESSON STATING THE DEVICE FAILED 30 PSI OCCLUSION TEST AND REQUIRED A HEX FILE INSTALLATION. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810235 Z-800F PUMP, INFUSION FRN ZYNO MEDICAL, LLC Z-800F 20140220-SH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown