MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-06-15 for HYPERABRIC CHAMBER 3300HR-00 manufactured by Sechrist Industries, Inc..
[2725658]
No pt involvement and was not yet placed into clinical use. A performance check was done after installation of the chamber. The test indicated the compression rate was at 5 psi/min with a setting of 1 psi/min. Several attempts to recalibrate conducted without any change in compression rate. When the rate was set to 5 psi/min the pressurization rate was 5 psi/min. There was no issue with decompression (it went at the proper rate)
Patient Sequence No: 1, Text Type: D, B5
[10117697]
Rate valve was changed and recalibrated. The chamber compressed and performed to specifications. Rate valve is enroute to mfr where it will be evaluated. Follow-up submission will be sent once the eval is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2012-00032 |
| MDR Report Key | 2625981 |
| Report Source | 06 |
| Date Received | 2012-06-15 |
| Date of Report | 2012-06-17 |
| Date of Event | 2012-05-18 |
| Device Manufacturer Date | 2011-07-08 |
| Date Added to Maude | 2012-10-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4225 EAST LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7145768400 |
| Manufacturer G1 | SECHRIST INDUSTRIES, INC. |
| Manufacturer Street | 4225 EAST LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92807 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPERABRIC CHAMBER |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2012-06-15 |
| Model Number | 3300HR-00 |
| Catalog Number | 3300HR-00 |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | 4225 EAST LA PALMA AVE. ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-15 |