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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction

• 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: sheryl higgins ; 1800 e. wilshire ave.; santa ana, CA 92705 ; +1(949)502-6448
• MDR Report Key: 50940562
• Report Number: 3014631252-2026-00079
• Device Sequence Number: 21514154
• Product Code: CBK
• UDI-Device Identifier: 00843685100159
• UDI-Public: (01)00843685100159(11)260330
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K222644
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2026
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 270 LB