BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-800 INFUSION SYSTEM

    MDR report key: 19778894 · Received July 18, 2024

    Report

    Report Number
    3006575795-2024-00575
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 18, 2024
    Report Date
    July 18, 2024
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020037
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING FUNCTIONAL TESTING, THE REPORTED ISSUE OF CONSTANT AIR IN LINE ALARM WAS NOT DUPLICATED. THERE WERE NO CONSTANT OR FALSE AIR-IN-LINE ALARMS GENERATED. THE DEVICE MEETS SPECIFICATION.

    Description of Event or Problem · 0

    ZYNO MEDICAL LLC, RECEIVED A REPORT THAT PUMP BEEPS AIR IN LINE ALARM WHEN THERE IS NO AIR IN THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917532 Z-800 INFUSION SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800WF 190722310 00814371020037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown