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

Model Number NKV-330

Device Problems Computer Software Problem (1112); Defective Component (2292); Low Readings (2460)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/19/2023

Event Type  malfunction  

Event Description

It was reported that pretesting was performed on the ventilator by the respiratory therapist.The patient was then placed on the nkv-330 ventilator with 100% oxygen.The ventilator began to alarm "low fio2" within minutes.Patient¿s oxygen level (spo2) decreased minimally.The respiratory therapist placed patient on another device.There was no patient harm.

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: 17733199
• MDR Text Key: 323509523
• Report Number: 3014631252-2023-00025
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 69 KG