BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-800 INFUSION SYSTEM

    MDR report key: 19743433 · Received July 15, 2024

    Report

    Report Number
    3006575795-2024-00518
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ZYNO MEDICAL LLC
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CAPA HAS BEEN OPENED TO INVESTIGATE THIS FAILURE MODE.

    Description of Event or Problem · 0

    ON 07/03/2024, ZYNO MEDICAL LLC RECEIVED A REPORT THAT THE DEVICE WAS REPORTED TO HAVE FAILED "30 PSI VALUE" CALIBRATION TEST UNDER REQUIRED PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256863 Z-800 INFUSION SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL LLC Z800F 20141024-SH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown