BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIHON KOHDEN NKV-550

    MDR report key: 23051714 · Received September 15, 2025

    Report

    Report Number
    23051714
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    June 23, 2025
    Report Date
    August 4, 2025
    Manufacturer
    NIHON KOHDEN ORANGEMED, LLC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE VENTILATOR SPONTANEOUSLY INITIATED AN INSPIRATORY HOLD MANEUVER ON THE PATIENT WITHOUT STAFF OPERATING THE MACHINE. DURING THE INSPIRATORY HOLD, THE PATIENT WAS ATTEMPTING TO TAKE SPONTANEOUS BREATHS AND WAS VISUALLY CONFIRMED ON THE VENTILATOR WAVEFORMS AND PATIENT MONITOR. THE ETCO2 [END-TIDAL CARBON DIOXIDE] TRACING REMAINED FLAT THROUGHOUT THE MANEUVER, AND RESPIRATORY RATE TRACING SHOWED CHEST MOVEMENT. STAFF ATTEMPTED TO STOP THE INSPIRATORY HOLD MULTIPLE TIMES, BUT THE SCREEN DID NOT RESPOND TO TOUCH INPUT AND CONTINUED THE MANEUVER UNINTERRUPTED. THE HOLD LASTED FOR A TOTAL OF 7.2 SECONDS, AFTER WHICH IT STOPPED AUTOMATICALLY WITHOUT MANUAL TERMINATION. THE MACHINE WAS SENT TO OUR BIO MEDICAL TEAM WHO WAS UNABLE TO REPLICATE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498872 NIHON KOHDEN NKV-550 VENTILATOR, CONTINUOUS, FACILITY USE CBK NIHON KOHDEN ORANGEMED, LLC NKV-550

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female