BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 9056940 · Received September 14, 2019

    Report

    Report Number
    3006575795-2019-00027
    Event Type
    Malfunction
    Date Received
    September 14, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 1, 2019
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020020
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THE PUMP WAS TESTED ON 07/19/2019 AND FAILED THE VOLUME TEST. THE SPEAKER ASSEMBLY WAS REPLACED AND THE PUMP WAS RETESTED TO MEET FULL SPECIFICATION. AN EMAIL WAS SENT TO ZYNO MEDICAL ON 07/19/2019 BY THE DISTRIBUTOR BUT THE DISTRIBUTOR DID NOT FOLLOW THE ESTABLISHED PROTOCOL TO FILL OUT THE COMPLAINT FORM UNTIL 09/12/2019. ZYNO MEDICAL DETERMINED THIS IS A MDR REPORTABLE EVENT ON 09/13/2019.

    Description of Event or Problem · 1

    ON 07/19/2019, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A SPEAKER MALFUNCTION ISSUE. A USER FACILITY REPRESENTATIVE EMAILED THE DISTRIBUTOR ON 07/01/2019, STATING THAT A PUMP HAD A SPEAKER THAT "WENT OUT, NO SOUND." NO PATIENT WAS INVOLVED. THE MEDICATION ASSOCIATED WITH THE INCIDENT WAS GAZVYA. DEVICE OPERATOR WAS A RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848661 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z-800W 20120222-SH 00814371020020

    Patients

    Seq Age Sex Outcome Treatment
    1