MAUDE Adverse Event Report: OXY HEALTH VITAERIS320 PORTABLE HYPERBARIC OXYGEN CHAMBER

Model Number VITAERIS 320

Device Problem Mechanics Altered (2984)

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

Event Date 01/07/2018

Event Type  malfunction  

Event Description

This involves the oxyhealth vitaeris320 portable hyperbaric oxygen chamber.There was no problem with the chamber's functionality but a design flaw with the cover caused what could have been a dangerous situation, at the end of a period of self-treating i attempted to emerge from the chamber but could not turn the pressure release valve.Ultimately i had to exert nearly my full strength to open the valve while lying on my back.After exiting i discovered that several threads where the cover had been sewn together had come loose and contacted the valve stem.When i closed the valve from inside the chamber, the threads from the cover wrapped around the valve stem which, as i closed it created a tight a seal around the stem which made it almost impossible to release the valve.A person of lesser strength than i, a small woman for example, would possibly have not been able to exit the chamber until someone from outside the chamber worked the valve loose.This is a danger for a person who chooses to self treat.

• Brand Name: VITAERIS320 PORTABLE HYPERBARIC OXYGEN CHAMBER
• Type of Device: PORTABLE HYPERBARIC OXYGEN CHAMBER
• Manufacturer (Section D): OXY HEALTH
• MDR Report Key: 7186485
• MDR Text Key: 97374768
• Report Number: MW5074543
• Device Sequence Number: 1
• Product Code: CBF
• UDI-Device Identifier: 10856039006011
• UDI-Public: (01)10856039006011
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VITAERIS 320
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR