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U.S. Department of Health and Human Services

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

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OXY HEALTH VITAERIS320 PORTABLE HYPERBARIC OXYGEN CHAMBER Back to Search Results
Model Number VITAERIS 320
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.

 
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Brand NameVITAERIS320 PORTABLE HYPERBARIC OXYGEN CHAMBER
Type of DevicePORTABLE HYPERBARIC OXYGEN CHAMBER
Manufacturer (Section D)
OXY HEALTH
MDR Report Key7186485
Report NumberMW5074543
Device Sequence Number1
Product CodeCBF
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVITAERIS 320
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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