MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-10 for MULTIX SELECT DR 10569624 manufactured by Siemens Shanghai Medical Equipment Ltd.
| Report Number | 3004754211-2019-99564 |
| MDR Report Key | 9174671 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-10 |
| Date of Report | 2019-09-17 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-11-26 |
| Device Manufacturer Date | 2016-11-14 |
| Date Added to Maude | 2019-10-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANASTASIA SOKOLOVA |
| Manufacturer Street | 40 LIBERTY BLVD, MC 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486478 |
| Manufacturer G1 | SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD |
| Manufacturer Street | 278 ZHOU ZHU ROAD |
| Manufacturer City | SHANGHAI, 201318 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 201318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIX SELECT DR |
| Generic Name | STATIONARY X-RAY SYSTEM |
| Product Code | KPR |
| Date Received | 2019-10-10 |
| Model Number | 10569624 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD |
| Manufacturer Address | 278 ZHOU ZHU ROAD SHANGHAI, 20131 CH 20131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-10 |