MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-11-08 for SECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER manufactured by Sechrist Industries, Inc..
| Report Number | 2020676-2019-00020 |
| MDR Report Key | 9301082 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-11-08 |
| Date of Report | 2019-10-11 |
| Date of Event | 2019-10-11 |
| Date Mfgr Received | 2019-10-11 |
| Device Manufacturer Date | 2018-07-19 |
| Date Added to Maude | 2019-11-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7145798313 |
| 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 | SECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2019-11-08 |
| Returned To Mfg | 2019-11-04 |
| Model Number | 3300H/HR |
| Catalog Number | 3300H/HR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-11-08 |