BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 19371540 · Received May 22, 2024

    Report

    Report Number
    3006575797-2024-00229
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    May 6, 2024
    Report Date
    May 20, 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

    THERE ARE PREVIOUS COMPLAINTS # (B)(4), ON THE DEVICE. TESTING RESULTS WERE REVIEWED. IT WAS DISCOVERED THAT THERE WERE DISCREPANCIES IN THE TEST RECORDS. NCR #2024-018 HAD BEEN INITIATED TO ADDRESS THE DISCREPANCIES. THIS FOLLOW-UP MDR WILL BE SUBMITTED IN THE EVENT 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 05/06/2024, ZYNO RECEIVED A REPORT THAT DURING PREVENTIVE MAINTENANCE THE FOLLOWING ISSUE WAS OBSERVED. THE PUMP HAD A SOFTWARE ISSUE, ZYNO WAS NOT ABLE TO CHANGE THE SOFTWARE AND DUE TO IT. IT WAS AFFECTING AIR IN THE LINE. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596519 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800F 20120910-SH 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown