MAUDE Adverse Event Report: NIHON KOHDEN ORANGEMED, INC. NIHON KOHDEN NKV-330 VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number NKV-330

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported that the patient had been on high flow oxygen therapy with the nkv-330 ventilator and after 18 hours of use, an alarm message ¿blower temp high¿ was noted.The respiratory therapist (rt) changed the dust filter on the ventilator and the ¿blower temp high¿ alarm message cleared.Approximately 3 hours later, the ¿blower temp high¿ alarm message occurred again.The rt stated that the nasal prongs were clear of mucous/secretions.The machine appeared to continue to provide high flow oxygen therapy with no significant changes in monitored parameters.The nkv-330 ventilator was switched out with another nkv-330 ventilator without complications.The patient was unresponsive throughout these occurrences, but no injury or harm was apparent.

Manufacturer Narrative

Nihon kohden orangemed inc.Will submit a supplemental report if additional information becomes available.

Manufacturer Narrative

Evaluation completed.See attached failure investigation summary report.

• Brand Name: NIHON KOHDEN NKV-330 VENTILATOR SYSTEM
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NIHON KOHDEN ORANGEMED, INC.; 1800 e. wilshire ave.; santa ana CA 92705
• Manufacturer (Section G): NIHON KOHEN ORANGEMED, INC.; 1800 e. wilshire ave.; santa ana CA 92705
• Manufacturer Contact: sheryl higgins ; 1800 e. wilshire ave.; santa ana, CA 92705 ; 949502644
• MDR Report Key: 17737193
• MDR Text Key: 323818326
• Report Number: 3014631252-2023-00027
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00843685100043
• UDI-Public: 00843685100043
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

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
• Device Operator: Health Professional
• Device Model Number: NKV-330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 MO
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Hispanic