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

Model Number NKV-330

Device Problems Defective Component (2292); Low Readings (2460)

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

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the nkv-330 ventilator kept alarming ''low fio2'' during patient use.The set fio2 was 40% and the measured fio2 was 27-34%.The patient was not harmed with spo2 and breathing rate normal.Patient was removed from this ventilator and placed on another ventilator.

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: 17470389
• MDR Text Key: 320503619
• Report Number: 3014631252-2023-00022
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00843685100043
• UDI-Public: 00843685100043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White