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 2019-11-18 for PRIMUS HI 4504200 manufactured by Siemens Healthcare Gmbh.
| Report Number | 3002466018-2019-05856 |
| MDR Report Key | 9335328 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-18 |
| Date of Report | 2019-11-04 |
| Date of Event | 2019-11-04 |
| Date Mfgr Received | 2019-11-04 |
| Date Added to Maude | 2019-11-18 |
| 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 | REBECCA TUDOR |
| Manufacturer Street | 40 LIBERTY BLVD. 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486484 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH |
| Manufacturer Street | ROENTGENSTRASSE 19-21 |
| Manufacturer City | KEMNATH, 95478 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 95478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMUS HI |
| Generic Name | ACCELERATOR, LINEAR, MEDICAL |
| Product Code | IYE |
| Date Received | 2019-11-18 |
| Model Number | 4504200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | ROENTGENSTRASSE 19-21 KEMNATH, 95478 GM 95478 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-18 |