MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-17 for 3500CP-G AIR/OXYGEN MIXER manufactured by Sechrist Industries, Inc..
| Report Number | 2020676-2020-00003 |
| MDR Report Key | 9842947 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2016-06-13 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| 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 AVE. |
| Manufacturer City | ANAHEIM, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 5798309 |
| Manufacturer G1 | SECHRIST INDUSTRIES INC. |
| Manufacturer Street | 4225 E. LA PALMA AVENUE |
| Manufacturer City | ANAHEIM, CA |
| Manufacturer Country | US |
| 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 | 2020-03-17 |
| Model Number | 3500CP-G |
| Catalog Number | 3500CP-G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |