MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-24 for HYPERBARIC CHAMBER 4100H/HR manufactured by Sechrist Industries, Inc..
| Report Number | 2020676-2019-00016 |
| MDR Report Key | 9112877 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-09-24 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-08-26 |
| Date Mfgr Received | 2019-08-26 |
| Device Manufacturer Date | 2013-07-26 |
| Date Added to Maude | 2019-09-24 |
| 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 | BIOMEDICAL ENGINEER |
| 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 |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7605798309 |
| 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 | HYPERBARIC CHAMBER |
| Product Code | CBF |
| Date Received | 2019-09-24 |
| Model Number | 4100H/HR |
| Catalog Number | 4100H/HR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-09-24 |