MAUDE Adverse Event Report: VARON/HONGKONG MAIDA TECHNOLOGY CO., LIMITED VARON 5L PULSE FLOW PORTABLE OXYGEN CONCENTRATOR VP-2; GENERATOR, OXYGEN, PORTABLE

Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The varon nt-2 oxygen concentrator is not capable of providing the oxygen flow rate of 5l/min as advertised.Oxygenation basics (https://www.Myamericannurse.Com/understanding-noninvasive-ventilation) "the type of non-invasive ventilation (niv) is based on the patient's required oxygen dose, which ss determined by the fraction of inspired oxygen (fi02) and the rate of oxygen flow (gas flow, liters/minute [l/min])." the above reference clearly identifies the use of liters/minute [l/min]is industry accepted abbreviation describing the oxygen flowrate.Throughout the advertisement varon nt-2 ? new arrival ?varon 1-5l/min pulse flow portable oxygen concentrator ¿ ttlife oxygen concentrator is advertised as 1-5l/min.Page 7 of the manual vp-2 manual (shopify.Com) for the unit identifies the maximum delivery volume as 50ml, or 1/100th per pulse.The pulses are at 3-second intervals for the flow rate of 1l/min.The nt-2 is not capable of providing 5l/min as advertised.Ttlife.

• Brand Name: VARON 5L PULSE FLOW PORTABLE OXYGEN CONCENTRATOR VP-2
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): VARON/HONGKONG MAIDA TECHNOLOGY CO., LIMITED
• MDR Report Key: 19722159
• Report Number: MW5157198
• Device Sequence Number: 18590546
• Product Code: CAW
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRELLEGY.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 168 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White