BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM

    MDR report key: 15473863 · Received September 23, 2022

    Report

    Report Number
    3014631252-2022-00012
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 27, 2022
    Report Date
    October 25, 2022
    Manufacturer
    NIHON KOHDEN ORANGEMED, INC.
    Product Code
    CBK
    UDI-DI
    00843685100012
    PMA / PMN Number
    K181695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION COMPLETED. SEE ATTACHED FAILURE INVESTIGATION SUMMARY REPORT.

    Additional Manufacturer Narrative · 0

    NIHON KOHDEN (B)(4) INC. WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT USE THE PATIENT STARTED TO DESATURATE (NOT DUE TO THE VENTILATOR), AND THE RESPIRATORY THERAPIST (RT) TRIED TO INCREASE THE O2 DELIVERY THROUGH THE GRAPHIC USER INTERFACE (GUI) TOUCHSCREEN. THE GUI TOUCHSCREEN WAS FROZEN AND NON-RESPONSIVE TO TOUCHING, ALTHOUGH THE GAS DELIVERY AND MONITORS OF THE VENTILATOR WERE UNAFFECTED. WHILE A NEW VENTILATOR WAS SET UP, THE PATIENT WAS HAND BAGGED, AND THEN THE VENTILATOR WAS CHANGED OUT. THERE WAS NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2827547 NIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM VENTILATOR, CONTINUOUS, FACILITY USE CBK NIHON KOHDEN ORANGEMED, INC. NKV-550-U 00843685100012

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DA Female Other