MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-11 for VITAERIS320 PORTABLE HYPERBARIC OXYGEN CHAMBER VITAERIS 320 manufactured by Oxy Health.
[97374768]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074543 |
| MDR Report Key | 7186485 |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-10 |
| Date of Event | 2018-01-07 |
| Date Added to Maude | 2018-01-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITAERIS320 PORTABLE HYPERBARIC OXYGEN CHAMBER |
| Generic Name | PORTABLE HYPERBARIC OXYGEN CHAMBER |
| Product Code | CBF |
| Date Received | 2018-01-11 |
| Model Number | VITAERIS 320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OXY HEALTH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-11 |