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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nihon kohden orangemed llc will submit a supplemental report if additional information becomes available.
Event or Problem Description
It was reported that prior to the respiratory therapist connecting the patient to the nkv-330 ventilator, the ventilator displayed a "low fio2" with a technical fault 00006 alarm message.The patient was not placed on this ventilator and was placed on another ventilator.There was no patient injury.The ventilator was brought to the biomed department for testing and verification.Clinical engineering verified the error message using a test lung, opened bdu to inspect visually, found nothing wrong, and reassembled.The ventilator was no longer alarming, but the event log showed the error message.
Additional Manufacturer Narrative
Evaluation completed.See attached failure investigation summary report.

• 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: 20894127
• Report Number: 3014631252-2024-00061
• Device Sequence Number: 8710303
• Product Code: MNT
• UDI-Device Identifier: 00843685100043
• UDI-Public: (01)00843685100043(11)230103
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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