MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2017-03-09 for HYPERBARIC CHAMBER 3600ER manufactured by Sechrist Industries, Inc..
[69564737]
Sechrist technician was dispatched onsite on 2/26/2016. Technician performed max pressure test, checked/inspected control panel tubings and other components for possible leaks. Performed chamber control system calibration iaw section 11. 5 (electronic control module manual). Performed & completed operational/verification. (b)(4) staff and technician ran chamber for 90 minutes w/rs of 1. 5 & ps of 2. 4 ata, chamber maintained pressure for duration of test. A review of the device history record (dhr) shows no indication that there were any relevant discrepancies during manufacturing and found no nonconformance that could cause or contribute to the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[69564738]
It was reported that hyperbaric chamber pressure drops from 2. 4ata to 2. 3ata. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020676-2017-00003 |
| MDR Report Key | 6393331 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-03-09 |
| Date of Report | 2016-02-23 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2016-02-23 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2017-03-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VICTOR ARELLANO |
| Manufacturer Street | 4225 E. LA PALMA AVENUE |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7145798400 |
| Manufacturer G1 | SECHRIST INDUSTRIES, INC. |
| Manufacturer Street | 4225 E. LA PALMA AVENUE |
| 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 | HYPERBARIC CHAMBER |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2017-03-09 |
| Model Number | 3600ER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | 4225 E. LA PALMA AVENUE ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-09 |