BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 19494823 · Received June 8, 2024

    Report

    Report Number
    3006575795-2024-00312
    Event Type
    Malfunction
    Date Received
    June 8, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 8, 2024
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020013
    PMA / PMN Number
    : K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE HISTORICAL RECORDS WERE REVIEWED. IT WAS DISCOVERED THAT THERE WERE DISCREPANCIES IN THE TEST RECORDS. NCR #2024-018 HAD BEEN INITIATED TO ADDRESS THE DISCREPANCIES. DEVICE RETURN REQUESTED. THIS MDR WILL BE REOPENED AND UPDATED IN THE EVENT THE DEVICE INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE. A CAPA HAS BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT. REFERENCE TO COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    ON 05/21/2024, ZNYO MEDICAL RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT ONE OF THE DEVICES HAD EXCEED LIMIT FOR THE FLOW IT NEEDED CALIBRATION. NO PATIENT WAS INVOLVED. THIS WAS DISCOVERED BY A BIOMED TECHNICIAN DURING TESTING AT ENBIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319014 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z-800F 181207428 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown