BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 10650043 · Received October 8, 2020

    Report

    Report Number
    3006575795-2020-00022
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Report Date
    September 17, 2020
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020006
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS TESTED BY THE SERVICE PROVIDER ON 04/10/2019. DURING THE TESTING, THE OCCLUSION ALARM FUNCTIONED TO SPECIFICATION. THE PUMP MET ALL SPECIFICATIONS AS INTENDED. THE REPORTED ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 04/03/2019, AND STATED THAT "PUMP 905282 CAME BACK FROM A FACILITY WITH A NOTE THAT SAID OCCLUSION". EVENT DATE IS UNKNOWN. THE OPERATOR OF THE DEVICE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVED OR NOT. THERE WAS NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113673 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z-800 20130511-SH 00814371020006

    Patients

    Seq Age Sex Outcome Treatment
    1