BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIHON KOHDEN NKV-330 VENTILATOR SYSTEM

    MDR report key: 17737481 · Received September 13, 2023

    Report

    Report Number
    3014631252-2023-00026
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 28, 2023
    Report Date
    December 21, 2023
    Manufacturer
    NIHON KOHDEN ORANGEMED, INC.
    Product Code
    MNT
    UDI-DI
    00843685100043
    PMA / PMN Number
    K213521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NIHON KOHDEN ORANGE MED INC. WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE''S SERIAL NUMBER ALONG WITH SYSTEM LOGS COULD NOT BE PROVIDED. AFTER NUMEROUS UNSUCCESSFUL ATTEMPTS TO RETRIEVE THE REQUESTED INFORMATION, NKOM PROCEEDED TO CLOSE OUT THIS COMPLAINT DUE TO INSUFFICIENT INFORMATION. NIHON KOHDEN ORANGEMED WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN ON HIGH FLOW OXYGEN THERAPY WITH THE NKV-330 VENTILATOR AND AFTER 12 HOURS OF USE, THE ALARM MESSAGE ¿BLOWER TEMP HIGH¿ WAS NOTED. THE MACHINE APPEARED TO CONTINUE TO PROVIDE HIGH FLOW OXYGEN THERAPY WITH NO SIGNIFICANT CHANGES IN MONITORED PARAMETERS. THE NKV-330 VENTILATOR WAS SWITCHED OUT WITH ANOTHER NKV-330 VENTILATOR WITHOUT COMPLICATIONS. THE PATIENT WAS UNRESPONSIVE THROUGHOUT THESE OCCURRENCES, BUT NO INJURY OR HARM WAS APPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059961 NIHON KOHDEN NKV-330 VENTILATOR SYSTEM VENTILATOR, CONTINUOUS, FACILITY USE MNT NIHON KOHDEN ORANGEMED, INC. NKV-330 UNKNOWN 00843685100043

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male