MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for GE ARCHITECT manufactured by Ge Healthcare Manufacturing Llc..
[184057094]
Metal procedure table pulled into the bore of a 3t magnet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093741 |
| MDR Report Key | 9829297 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-09 |
| Date Added to Maude | 2020-03-13 |
| 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | GE ARCHITECT |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE |
| Product Code | LNH |
| Date Received | 2020-03-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE MANUFACTURING LLC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-12 |