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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after retaping the patient's endotracheal tube, the user manually ventilated the patient and transitioned the patient to the nkv-550 ventilator.Although the ventilator delivered ventilation, tidal volumes decreased to approximately 2 cc/kg, and alarms were triggered for low tidal volume (cc/kg) and loss of etco2.The patient lost vital signs, and manual ventilation was initiated.The patient then stabilized.The patient was transitioned to another ventilator, and ventilation was successfully maintained.The user reported there was no harm or serious injury to the patient.The respiratory therapist performed troubleshooting at the bedside, including a calibration attempt.The circuit check passed; however, the device check failed during the safety valve test and displayed the message, 'system failure ¿ make sure safety valve is installed correctly.' following the removal of the ventilator from the patient's room, a biomedical engineer conducted multiple operational checks, all of which passed.After the device was returned to nihon kohden orangemed, it underwent comprehensive functional and performance testing.The device successfully passed all applicable tests during this evaluation.Log analysis confirmed that the patient was on simv-pc/ps, with pc 10 cmh2o, ps 10 cmh2o, peep 5 cmh2o, and fio2 100%.During the time period of the event, the ventilator continued to deliver the correct set pressure as programmed.The device recorded a significant reduction in tidal volume (vt).The ventilator initiated low tidal volume alarms as a result.During the event, the safety valve remained closed during ventilation, as evidenced by the pressure and volume data.Based on the available information, the reported ¿low tidal volume¿ is most likely attributable to an obstruction in the patient's airway and/or to endotracheal tube issues after retaping, rather than to a device-related problem.
Additional Manufacturer Narrative
The failure investigation is ongoing.Nihon kohden orangemed llc will submit a supplemental report upon completion of the full investigation.
Additional Manufacturer Narrative
Evaluation completed.

• 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: 24333864
• Report Number: 3014631252-2026-00010
• Device Sequence Number: 21275506
• Product Code: CBK
• UDI-Device Identifier: 00843685100012
• UDI-Public: (01)00843685100012(11)210127
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NKV-550-U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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: 8 MO
• Patient Sex: Female
• Patient Weight: 9 KG
• Patient Ethnicity: Hispanic