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 2017-09-17 for HYPERBARIC CHAMBER 3600E/ER manufactured by Sechrist Industries, Inc..
[87317784]
Sechrist technician was dispatched onsite and evaluated decompression and emergency vent on the chamber. Technician found that exhaust screen was dirty, removed screen and chamber decompresses normally. Technician instructed customer to remove, inspect screen and clean out at least once month. A device history review was performed (dhr) chamber 3600e/er serial number (b)(4) was manufactured on 03/12/2006. There is no indication that there were any relevant discrepancies during manufacturing. A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[87317785]
Sechrist is submitting this medwatch report in response to medsun report # (b)(4). On (b)(6) 2017 customer reported decompression issues with their hyperbaric chamber 3600e/er. Customer stated that the emergency vent is slow and decompression rate is also slow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020676-2017-00023 |
| MDR Report Key | 6871400 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-09-17 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-06-26 |
| Date Mfgr Received | 2017-06-26 |
| Device Manufacturer Date | 2006-03-12 |
| Date Added to Maude | 2017-09-17 |
| 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. MAJID MASHAYEKH |
| Manufacturer Street | 4225 E. LA PALMA AVENUE |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| 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 3600E/ER |
| Generic Name | HYPERBARIC CHAMBER 3600E/ER |
| Product Code | CBF |
| Date Received | 2017-09-17 |
| Model Number | 3600E/ER |
| 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 | 2017-09-17 |