BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 3830410 · Received May 13, 2014

    Report

    Report Number
    3006575795-2014-00005
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 27, 2014
    Manufacturer
    ZYNO MEDICAL LLC.
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO DUPLICATE REPORTED ISSUE. DEVICE PERFORMED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE HAD AN AIR IN LINE INCIDENT. A SITE DOCTOR WAS CALLED IN TO LOOK OVER THE PATIENT AND HE WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285505 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOL. PERISTALTIC INFUSION PUMP FRN ZYNO MEDICAL LLC. Z-800WF 20131217-SH

    Patients

    Seq Age Sex Outcome Treatment
    1