MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-01 for GE SIGNA MRI SCANNER 1.5 HDX manufactured by Ge Medical Systems Llc.
[46262368]
Patient Sequence No: 1, Text Type: N, H10
[46262369]
Scan commenced at 11:55 with anesthesia; at approximately 12:30 scanner images were not clear/readable - coil changed. Patient rescanned, images unable to be collected. Several attempts were made to collect images and the engineers were called, but scanner failed. At 14:38 scan aborted.
Patient Sequence No: 1, Text Type: D, B5
[46666193]
Patient Sequence No: 1, Text Type: N, H10
[46666194]
Scan commenced at 11:55 with anesthesia; at approximately 12:30 scanner images were not clear/readable - coil changed. Patient rescanned, images unable to be collected. Several attempts were made to collect images and the engineers were called, but scanner failed. At 14:38 scan aborted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5690719 |
| MDR Report Key | 5690719 |
| Date Received | 2016-06-01 |
| Date of Report | 2016-05-16 |
| Date of Event | 2016-05-12 |
| Report Date | 2016-05-16 |
| Date Reported to FDA | 2016-05-16 |
| Date Reported to Mfgr | 2016-05-16 |
| Date Added to Maude | 2016-06-01 |
| 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 SIGNA MRI SCANNER |
| Generic Name | COIL, MAGNETIC RESONANCE, SPECIALTY |
| Product Code | MOS |
| Date Received | 2016-06-01 |
| Model Number | 1.5 HDX |
| ID Number | 213825 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS LLC |
| Manufacturer Address | 3200 N. GRANDVIEW BLVD. WAUKESHA, WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-01 |