MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-31 for VITAERIS VITAERIS 320 manufactured by Hyperbaric Technologies Inc./ Oxyhealth.
[35182937]
A nurse was treating a patient in a vitaeris 320 hyperbaric chamber. It came time to depressurize the chamber and right after she turned the knob to let the pressure out, the vitaeris 320 hyperbaric chamber exploded causing the zipper to rip off. A white dust blew out everywhere and the patient and nurse were pretty shaken up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058949 |
| MDR Report Key | 5348134 |
| Date Received | 2015-12-31 |
| Date of Report | 2015-12-31 |
| Date of Event | 2015-12-29 |
| Date Added to Maude | 2016-01-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | VITAERIS |
| Generic Name | PORTABLE HYPERBARIC CHAMBER |
| Product Code | CBF |
| Date Received | 2015-12-31 |
| Model Number | VITAERIS 320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYPERBARIC TECHNOLOGIES INC./ OXYHEALTH |
| Manufacturer Address | 10719 NORWALK BLVD. SANTA FE SPRINGS CA 90670 US 90670 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-31 |