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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator-related event was reported to nkom from medwatch.The ventilator's etco2 alarm activated while the patient appeared to be breathing above their normal respiratory rate.The respiratory therapist observed abnormal ventilator behavior, including intermittent touchscreen display malfunction ("glitching") and repetitive, unintended activation and deactivation of the expiratory hold function.Attempts to cancel the expiratory hold by selecting the on-screen "x" were unsuccessful, as the ventilator did not respond to user input.During the event, the patient experienced oxygen desaturation; however, no serious injury or lasting patient harm was reported.The clinical team prepared to initiate manual ventilation using a bag-valve mask.Before manual ventilation was required, the ventilator spontaneously returned to normal operation without intervention.The ventilator was replaced with another ventilator.Biomedical engineering evaluated the device following the event.Functional testing, operational verification, and extended monitoring of the touchscreen display were performed.The device passed all testing and was found to be operating within manufacturer specifications.The reported touchscreen malfunction and unintended expiratory hold behavior could not be reproduced, and no display abnormalities were observed during evaluation.The device was returned to service following successful testing.This event represents an isolated, non-reproducible ventilator malfunction that resolved spontaneously and could not be confirmed during subsequent evaluation.
Additional Manufacturer Narrative
Nihon kohden orangemed llc will submit a supplemental report if additional information becomes available.

• 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: 25568265
• Report Number: 3014631252-2026-00042
• Device Sequence Number: 16023944
• Product Code: CBK
• UDI-Device Identifier: 00843685100012
• UDI-Public: (01)00843685100012(11)201210
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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-550-U
• 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: 05/26/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2020
• 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: 24 MO
• Patient Sex: Male
• Patient Weight: 22 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White