MAUDE Adverse Event Report: NIHON KOHDEN ORANGEMED, LLC NIHON KOHDEN NKV-440 VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	NKV-440-S
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation has been completed.Refer to the attached failure investigation summary report for detailed findings.The reported event was caused by contamination of the exhalation valve and exhalation flow sensor from aerosolized medication associated with nebulizer treatments.There was no evidence of a ventilator design defect, manufacturing defect, or software malfunction.Post-event testing confirmed that cleaning the exhalation valve and flow sensor restored normal ventilator function.The observed failure mode is consistent with warnings and maintenance instructions in the nkv-440 operator¿s manual regarding nebulizer use and the need for expiratory filter replacement, and cleaning of the exhalation valve.The ventilator alarms functioned as designed by detecting abnormal conditions caused by contamination of the expiratory pathway.
Event or Problem Description
It was reported to nkom that during initiation of nebulizer treatment, the ventilator began generating "circuit disconnect" and "circuit obstruction" alarms.The respiratory therapist (rt) observed that the displayed exhaled tidal volume (vte) and respiratory rate (rr) intermittently fluctuated between appropriate values and zero, despite the patient continuing to breathe and trigger the ventilator.As a precaution, the patient was disconnected from the ventilator and manually ventilated with a resuscitation bag before being transitioned to another ventilator.There was no patient harm as the patient remained stable before, during, and after the event.Follow-up information from the rt on (b)(6) 2026, stated that the patient received duoneb nebulizer treatments every 6 hours and was lavage suctioned as needed.Troubleshooting was performed, including inspection of the patient circuit for disconnections, leaks, or occlusions, and lavage suctioning of the patient, which yielded an insignificant amount of secretions.Additionally, the ventilator was reported to emit an intermittent motorized or whirring noise.When the patient was placed on another ventilator, the patient tolerated the same ventilator settings on the replacement device without further issue.The hospital user stated that at the time of the event, hospital policy required replacing the hepa filter monthly.The user further indicated that updated instructions now require daily hepa filter replacement.The hepa filter had not been changed on the day of the event.The reporting hospital declined to provide patient demographic information.Nkom conducted an evaluation and concluded that the reported event was caused by contamination of the exhalation valve and exhalation flow sensor from aerosolized medication associated with nebulizer treatments.There was no evidence of a ventilator design defect, manufacturing defect, or software malfunction.Post-event testing confirmed that cleaning the exhalation valve and flow sensor restored normal ventilator function.The observed failure mode is consistent with warnings and maintenance instructions in the nkv-440 operator¿s manual regarding nebulizer use and the need for expiratory filter replacement, and cleaning of the exhalation valve.The ventilator alarms functioned as designed by detecting abnormal conditions caused by contamination of the expiratory pathway.

• Brand Name: NIHON KOHDEN NKV-440 VENTILATOR SYSTEM
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NIHON KOHDEN ORANGEMED, LLC; 1800 e. wilshire ave.; santa ana CA 92705
• Manufacturer (Section G): NIHON KOHEN ORANGEMED, LLC; 1800 e. wilshire ave.; santa ana CA 92705
• Manufacturer Contact: sheryl higgins ; 1800 e. wilshire ave.; santa ana, CA 92705 ; 949502644
• MDR Report Key: 25615103
• Report Number: 3014631252-2026-00044
• Device Sequence Number: 18751491
• Product Code: CBK
• UDI-Device Identifier: 00843685100159
• UDI-Public: (01)00843685100159(11)241011
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NKV-440-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown