MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-13 for VITAERIS 320 PACKAGE V320 manufactured by Oxyhealth, Llc.
[114197852]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078391 |
| MDR Report Key | 7689303 |
| Date Received | 2018-07-13 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-07-09 |
| Date Added to Maude | 2018-07-16 |
| 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 | VITAERIS 320 PACKAGE |
| Generic Name | HYPERBARIC CHAMBER |
| Product Code | CBF |
| Date Received | 2018-07-13 |
| Model Number | V320 |
| Catalog Number | VITAERIS |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OXYHEALTH, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-13 |