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	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
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 the respiratory therapist (rt) performed a circuit check and o2 calibration and ensured they both passed on the nkv-330 ventilator while setting up the ventilator for patient use during a rapid response.Default settings on nkv-330 were mode: s/t, ipap: 10, epap 5, and fio2 21%.The rt adjusted settings to s/t ipap 14, epap 8, and 60% fio2.The rt pressed start ventilation.The ventilator began alarming and showing alarm messages (in order) technical fault 00011, vent inop.00006, and check prox.Pressure line.The rt did not place the patient on the nkv-330 ventilator; instead, the patient was placed on another ventilator.There was no patient harm.
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: 21021473
• Report Number: 3014631252-2024-00063
• Device Sequence Number: 19825697
• Product Code: MNT
• UDI-Device Identifier: 00843685100043
• UDI-Public: (01)00843685100043(11)240904
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic