MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-04 for BS-2000M CHEMISTRY ANALYZER BA2KA-CTO-S01 manufactured by Shenzhen Mindray Bio-medical Electronics Co., Ltd.
| Report Number | 3009156722-2019-00006 |
| MDR Report Key | 9271865 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-04 |
| Date of Report | 2019-10-11 |
| Date of Event | 2019-09-27 |
| Date Mfgr Received | 2019-10-11 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2019-11-04 |
| 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 | MS. SERENA CHEN |
| Manufacturer Street | 1203 NANHUAN AVENUE GUANGMING DISTRICT |
| Manufacturer City | SHENZHEN, GUANGDONG 518106 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BS-2000M CHEMISTRY ANALYZER |
| Generic Name | BS-2000M |
| Product Code | JGS |
| Date Received | 2019-11-04 |
| Model Number | BA2KA-CTO-S01 |
| Catalog Number | BA2KA-CTO-S01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Manufacturer Address | 1203 NANHUAN AVENUE GUANGMING DISTRICT SHENZHEN, 518106 CH 518106 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-04 |