MAUDE Adverse Event Report: OXYHEALTH, LLC VITAERIS 320 PACKAGE; HYPERBARIC CHAMBER

Model Number V320

Device Problems Gas Output Problem (1266); Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2018

Event Type  malfunction  

Event Description

Used an oxyhealth vitaeris 320.The oxygen concentrator package they sold directly to me stopped working and started rumbling loudly and couldn't breathe while in the unit, the mask was not supplying oxygen.I called them to complain and they claimed they don't sell it, but i have an invoice of the product and spent the money, oxyhealth said they would give me a deal and charge (b)(6).However, when i called they said they don't sell it and won't fix the concentrator.

• Brand Name: VITAERIS 320 PACKAGE
• Type of Device: HYPERBARIC CHAMBER
• Manufacturer (Section D): OXYHEALTH, LLC
• MDR Report Key: 7689303
• MDR Text Key: 114197852
• Report Number: MW5078391
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2018

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: Lay User/Patient
• Device Model Number: V320
• Device Catalogue Number: VITAERIS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 56