MAUDE Adverse Event Report: NIHON KOHDEN ORANGEMED, LLC NIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	NKV-550-U
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation completed.
Event or Problem Description
It was reported that during patient use, the ventilator rebooted and displayed the error message: ¿unit restarted, check settings, check apps activated.¿ following the reboot, the ventilator resumed ventilating the patient.As a precaution, clinical staff transferred the patient to another ventilator and removed the affected device from service.There was no patient harm reported as a result of the event.The reporting hospital declined to provide patient demographic information.A review of the device logs confirmed a momentary cpu reset, with ventilation recovery occurring within 15 seconds.By design, audible and visual alarms are annunciated when the momentary system restart occurs.

• Brand Name: NIHON KOHDEN NKV-550 SERIES 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: 24611714
• Report Number: 3014631252-2026-00021
• Device Sequence Number: 18676425
• Product Code: CBK
• UDI-Device Identifier: 00843685100012
• UDI-Public: (01)00843685100012(11)250904
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K192307
• 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): 03/16/2026

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
• Device Model Number: NKV-550-U
• 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: 02/19/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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