BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 19121678 · Received April 16, 2024

    Report

    Report Number
    3006575795-2024-00113
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 22, 2024
    Report Date
    April 16, 2024
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020013
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON(B)(6) 2024 FLOWRATE ISSUE WAS OBSERVED DURING PREVENTIVE MAINTENANCE ACTIVITIES PERFORMED AT ZYNO MEDICAL, LLC. CAUSE NOT ESTABLISHED AS THERE IS A TRACK OF YEARLY MAINTENANCE DONE ON THIS DEVICE FOR YEARS 2024 AND 2023.. ALL THE ISSUES RESOLVED/REPAIRED AS THIS IS OBSERVED DURING PREVENTIVE MAINTENANCE. A CAPA HAS BEEN OPENED IN ORDER TO FULLY DIAGNOSE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024 DURING SERVICING ACTIVITIES OF ZYNO MEDICAL, LLC WHICH INCLUDES PREVENTIVE MAINTENANCE THERE IS A FLOWRATE OFFSET% ISSUE WHERE FLOWRATE OFFSET% AT PRE-REWORK IS (B)(4) AND AT POST-REWORK IT IS (B)(4).NO PATIENT INVOLVED AS THIS IS OBSERVED DURING PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893557 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800F 201211740 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown