MAUDE Adverse Event Report: Nihon Kohden OrangeMed, LLC Nihon Kohden NKV-550 Series Ventilator System; Ventilator, Continuous, Facility Use

Model Number	NKV-550-S
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction

• 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 ; +1(949)502-6448
• MDR Report Key: 50940495
• Report Number: 3014631252-2026-00078
• Device Sequence Number: 21517589
• Product Code: CBK
• UDI-Device Identifier: 00843685100005
• UDI-Public: (01)00843685100005(11)260212
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K192307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: 505
• 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: Other
• Device Model Number: NKV-550-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 02/12/2026
• 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 Sex: Unknown