MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for DISCOVERY MR750W 3.0T manufactured by Ge Medical Systems, Llc.
[173466544]
While bringing patient into the mri scan room for her outpatient magnetic resonance angiography (mra) brain, the patient's glasses were pulled off of her face and flew into the scanner bore. The glasses broke in half when they struck the inside of the bore. No injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9543051 |
| MDR Report Key | 9543051 |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-19 |
| Report Date | 2019-12-20 |
| Date Reported to FDA | 2019-12-20 |
| Date Reported to Mfgr | 2020-01-03 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | DISCOVERY MR750W 3.0T |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-01-03 |
| Model Number | MR750W |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 N GRANDVIEW BLVD WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |