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 2020-02-19 for INGENIA ELITION X 781358 manufactured by Philips Electronics Nederland B.v..
[183719008]
Philips received a report on a fire incident with the magnet of an ingenia elition x mr system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2020-01000 |
| MDR Report Key | 9726343 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-19 |
| Date of Event | 2020-02-05 |
| Date Facility Aware | 2020-02-05 |
| Date Added to Maude | 2020-02-19 |
| 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 | MR. DUSTY LEPPERT |
| Manufacturer Street | VEENPLUIS 6 |
| Manufacturer City | BEST 5684PC |
| Manufacturer Country | NL |
| Manufacturer Postal | 5684 PC |
| Manufacturer G1 | PHILIPS ELECTRONICS NEDERLAND B.V. |
| Manufacturer Street | VEENPLUIS 6 |
| Manufacturer City | BEST 5684PC |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 5684 PC |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INGENIA ELITION X |
| Generic Name | INGENIA ELITION X |
| Product Code | LNH |
| Date Received | 2020-02-19 |
| Model Number | INGENIA ELITION X |
| Catalog Number | 781358 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ELECTRONICS NEDERLAND B.V. |
| Manufacturer Address | VEENPLUIS 6 BEST 5684PC NL 5684 PC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-19 |