MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-05-21 for VITAERES 320 manufactured by Hyperbaric Technologies, Inc..
[19408489]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19451910]
Five samples of the air hose connector (p/n hfc 17612 by colder products co) (identical to the part on #3398) were randomly selected from inventory and performance testing was conducted and all five found to be per specifications. The air hose was attached to a vitaeres 320 hyperbaric chamber and tests were conducted to make the connector fail but the connector remained intact. The only way to make it disconnect other than by hand was to have a stationary blunt object next to the exact center of the push button release and after 3. 5 pounds of pressure, it disconnected. We have concluded that given the perfect safety record of over 13 year and (b)(4) chambers using this device, and the extreme unlikelihood of this ever to happen again we feel most confident in its use. The ifus of this product recommend that use of the device include supervision.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2438426-2014-00001 |
| MDR Report Key | 3838678 |
| Report Source | 08 |
| Date Received | 2014-05-21 |
| Date Mfgr Received | 2014-04-22 |
| Device Manufacturer Date | 2005-09-15 |
| Date Added to Maude | 2014-05-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PETER LEWIS |
| Manufacturer Street | ONE SAM STRATTON RD. |
| Manufacturer City | AMSTERDAM NY 12010 |
| Manufacturer Country | US |
| Manufacturer Postal | 12010 |
| Manufacturer Phone | 5188423030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAERES 320 |
| Generic Name | 73CBF |
| Product Code | CBF |
| Date Received | 2014-05-21 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYPERBARIC TECHNOLOGIES, INC. |
| Manufacturer Address | ONE SAM STRATTON RD. AMSTERDAM NY 12010 US 12010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-21 |