MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-25 for 16.2.1 PINNACLE3 SW 459801419351 manufactured by Philips Medical Systems.
| Report Number | 3004022368-2019-00002 |
| MDR Report Key | 9120714 |
| Date Received | 2019-09-25 |
| Date of Report | 2019-08-27 |
| Date Mfgr Received | 2019-09-10 |
| Date Added to Maude | 2019-09-25 |
| 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 | MRS. JILL KAEDER |
| Manufacturer Street | 5520 NOBEL DRIVE, SUITE 125 |
| Manufacturer City | FITCHBURG WI 53711 |
| Manufacturer Country | US |
| Manufacturer Postal | 53711 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer City | FITCHBURG WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 16.2.1 PINNACLE3 SW |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | MUJ |
| Date Received | 2019-09-25 |
| Model Number | 459801419351 |
| Catalog Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 5520 NOBEL DRIVE, SUITE 125 FITCHBURG WI 53711 US 53711 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-25 |