MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-21 for INGENIA 3.0T 781377 manufactured by Philips Medical Systems Nederland B.v..
| Report Number | MW5090531 |
| MDR Report Key | 9218913 |
| Date Received | 2019-10-21 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-10-16 |
| Date Added to Maude | 2019-10-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INGENIA 3.0T |
| Generic Name | NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2019-10-21 |
| Model Number | INGENIA |
| Catalog Number | 781377 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-21 |