MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for GE 1.5T GEM HNU 5372735 manufactured by Ge Healthcare.
[89846356]
Patient Sequence No: 1, Text Type: N, H10
[89846358]
The mri machine malfunctioned when the coil broke making un-usable for patient care. Manufacturer response for mri coil, ge 1. 5t gem hnu (per site reporter): field representative to site to replace mri coil. Field representative took faulty coil with him after replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6965176 |
| MDR Report Key | 6965176 |
| Date Received | 2017-10-20 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-08-21 |
| Report Date | 2017-09-11 |
| Date Reported to FDA | 2017-09-11 |
| Date Reported to Mfgr | 2017-09-11 |
| Date Added to Maude | 2017-10-20 |
| 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 |
| 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 1.5T GEM HNU |
| Generic Name | COIL, MAGNETIC RESONANCE |
| Product Code | MOS |
| Date Received | 2017-10-20 |
| Returned To Mfg | 2017-08-22 |
| Model Number | 1.5T GEM HNU |
| Catalog Number | 5372735 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 3200 N GRANDVIEW BLVD WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |