MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-26 for MAGNETOM ESSENZA 10352127 manufactured by Siemens Shenzhen Magnetic Resonance Ltd..
| Report Number | 3004754211-2020-20005 |
| MDR Report Key | 9756143 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-02-26 |
| 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 | MEREDITH ADAMS |
| Manufacturer Street | 40 LIBERTY BLVD. 65-1A |
| Manufacturer City | MALVERN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 4486461 |
| Manufacturer G1 | SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. |
| Manufacturer Street | GAOXIN C AVE. 2ND, HI-TECH INDUSTRIAL PARK |
| Manufacturer City | SHENZHEN, CHINA 518057 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 518057 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNETOM ESSENZA |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-02-26 |
| Model Number | 10352127 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. |
| Manufacturer Address | GAOXIN C AVE. 2ND, HI-TECH INDUSTRIAL PARK SHENZHEN, CHINA 518057 CH 518057 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-26 |