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 06/08/2023

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 during patient use, the ventilator was alarming low fio2.The fio2 was set at 100% and the measured fio2 was reading 87%.The ventilator continued to ventilate the patient and the patient did not desaturate.The customer also stated that this same phenomenon occurred with this ventilator on another patient two weeks prior but they did not report incident to nihon kohden orangemed.There was no reported harm to either patient and both patients were 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: 17321367
• MDR Text Key: 319384843
• Report Number: 3014631252-2023-00019
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NKV-330
• Device Catalogue Number: NKV-330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White