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 Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator displayed an ¿internal airflow sensor failure¿ and a high fio2 alarm while ventilating a patient.The set fio2 was at 50%, but the monitored value showed fio2 at 100%.There was no reported patient harm.
Additional Manufacturer Narrative
Nihon kohden orangemed llc will submit a supplemental report if additional information becomes available.
Additional Manufacturer Narrative
Additional information added.Nihon kohden orangemed llc will submit a supplemental report if additional information becomes available.
Event or Problem Description
It was reported that as the user placed the patient on the ventilator, it began to alarm ¿internal airflow sensor failure¿ and high fio2.The ventilator continued to ventilate the patient.The set fio2 was at 50%, but the monitored value showed fio2 at 100%.The user placed the patient on another ventilator, and there was no harm to the patient.
Additional Manufacturer Narrative
Evaluation completed.See attached failure investigation summary report.

• 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: l higgins ; 1800 e. wilshire ave.; santa ana, CA 92705 ; 949502644
• MDR Report Key: 22075428
• Report Number: 3014631252-2025-00032
• Device Sequence Number: 9337877
• Product Code: CBK
• UDI-Device Identifier: 00843685100159
• UDI-Public: (01)00843685100159(11)241210
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K222644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/12/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic