MAUDE Adverse Event Report: NIHON KOHDEN ORANGEMED, LLC NIHON KOHDEN NKV-330 VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	NKV-330
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation has been completed.The device log data analyses indicate that there was no ventilator shutdown or any similar event.Delivered flow was maintained throughout the ventilation period from the start of ventilation until the end of ventilation, indicating that ventilation continued.The ventilator performed as designed with no indication of malfunction.Refer to the attached failure investigation summary report for detailed findings.
Event or Problem Description
It was reported that the respiratory therapist (rt) was adjusting the patient interface to achieve an adequate mask seal.The ventilator was reported as ¿not working¿ and appeared to shut off during use.No waveforms were observed on the device display at the time of the reported event.The patient was subsequently intubated and transitioned to an alternate ventilator.No other harm, severe injury, or death was reported.The device log data analyses performed by nihon kohden orangemed indicated there was no ventilator shutdown or any similar event.Delivered flow was maintained throughout the ventilation period from the start of ventilation until the end of ventilation, indicating that ventilation continued.Nihon kohden orangemed concluded that the ventilator performed as designed with no indication of malfunction.

• Brand Name: NIHON KOHDEN NKV-330 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: 25138053
• Report Number: 3014631252-2026-00033
• Device Sequence Number: 9453886
• Product Code: MNT
• UDI-Device Identifier: 00843685100043
• UDI-Public: (01)00843685100043(11)260203
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K213521
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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-330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 65 KG