MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-06 for 3500CP-G AIR/OXYGEN MIXER manufactured by Sechrist Industries Inc..
| Report Number | 2020676-2020-00002 |
| MDR Report Key | 9555929 |
| Report Source | OTHER |
| Date Received | 2020-01-06 |
| Date of Report | 2019-12-09 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2013-12-02 |
| Date Added to Maude | 2020-01-06 |
| 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 | 7145798309 |
| 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 | 3500CP-G AIR/OXYGEN MIXER |
| Generic Name | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Product Code | DTX |
| Date Received | 2020-01-06 |
| Model Number | 3500CP-G |
| Catalog Number | 3500CP-G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-06 |