MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-28 for CHAMBER, HYPERBARIC 3200R manufactured by Sechrist Industries, Inc..
[3002131]
During scheduled testing the tech noted that the chamber is compressing outside of mfr specifications. Set at a rate of 1, the chamber is compressing at 1 psi per 43 seconds. This rate is faster than the specified rate.
Patient Sequence No: 1, Text Type: D, B5
[10260854]
The chamber had previously received its annual service maintenance on (b)(4) 2012. No issues regarding the functionality were noted on the report. Evaluation of the chamber verified the reported failure. At a rate of 1 the chamber was compressing 1psi per 44 seconds. The rate valve was replaced and the chamber was performance verified. It was found to function per factory specification. A request for the original rate valve has been made. An update will be sent upon eval of the rate valve.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2012-00051 |
| MDR Report Key | 2854339 |
| Report Source | 06 |
| Date Received | 2012-11-28 |
| Date of Report | 2012-11-28 |
| Date of Event | 2012-10-24 |
| Date Mfgr Received | 2012-10-29 |
| Device Manufacturer Date | 2004-04-22 |
| Date Added to Maude | 2013-03-04 |
| 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 | 7145798400 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAMBER, HYPERBARIC |
| Generic Name | HYPERBARIC MONOPLACE CHAMBER |
| Product Code | CBF |
| Date Received | 2012-11-28 |
| Model Number | 3200R |
| Catalog Number | 3200R |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-11-28 |