MAUDE Adverse Event Report: VARON, INC. / HONGKONG MAIDA TECHNOLOGY CO., LIMITED VARON VP-2 (ALSO CALLED NT-2); GENERATOR, OXYGEN, PORTABLE

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
I bought an oxygen concentrator from varon, lnc.It didn't produce enough oxygen, but the company said that for a fee, i could upgrade to a product called the vp-2, which produces 5 l/min of oxygen.I paid the second fee and paid to ship the first product back.When the vp-2 arrived, though, i learned that it only produces (per its manual) 1 l/min of oxygen.I wrote to the company about their illegal false advertising -- both on their website and in writing to me -- and they refused to help me.They kept repeating the absurd lie that "l/min" doesn't mean "liters per minute," but is instead an abbreviation of the word "level." they are lying to sick and disabled people in order to scam them out of money by selling them useless medical products.

• Brand Name: VARON VP-2 (ALSO CALLED NT-2)
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): VARON, INC. / HONGKONG MAIDA TECHNOLOGY CO., LIMITED
• MDR Report Key: 21333591
• Report Number: MW5165745
• Device Sequence Number: 15417348
• Product Code: CAW
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/31/2025

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
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White