BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 6841931 · Received September 5, 2017

    Report

    Report Number
    3006575795-2017-00262
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    August 23, 2017
    Report Date
    August 30, 2017
    Manufacturer
    ZYNO MEDICAL LLC
    Product Code
    FRN
    UDI-DI
    00814371020006
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ZYNO MEDICAL HAS REPAIRED AND TESTED THE DEVICE TO FULL SPECIFICATIONS ON (B)(6) 2017. THE PUMP PERIODIC PREVENTIVE MAINTENANCE (PM) INTERVAL RECOMMENDED BY ZYNO MEDICAL IN THE INSTRUCTIONS FOR USE (IFU) IS ONE YEAR. OUR COMPANY RECORDS INDICATE THAT THE LAST PM PERFORMED BY ZYNO MEDICAL FOR THIS PUMP WAS ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE PUMP WAS IDENTIFIED WITH A FLOW RATE ACCURACY ISSUE DURING PERIODIC MAINTENANCE TESTING ON (B)(6) 2017. THE DEVICE WAS FOUND TO HAVE A FLOW RATE ACCURACY OF (B)(4). NO PATIENT WAS INVOLVED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622988 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL LLC Z-800 20100420-D 00814371020006

    Patients

    Seq Age Sex Outcome Treatment
    1