MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-17 for GE DEFINIUM 8000 * manufactured by Ge Healthcare.
[2974747]
Three patients had discrepancy of date of exam. Correct worklist, but incorrect on recorded exams. Determined that the operating system had crashed rendering the system unusable. Manufacturer's technician completed a "load from cold" procedure and reloaded the operating system and applications including patch software. Restored customer settings and protocols from saved disks and tested systems functionality. Also confirmed that time/date was correct for recorded test exams. System passed all function tests and is ready for use. We have not had this kind of problem/event in the past.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2753159 |
| MDR Report Key | 2753159 |
| Date Received | 2012-09-17 |
| Date of Report | 2012-09-17 |
| Date of Event | 2012-08-20 |
| Report Date | 2012-09-17 |
| Date Reported to FDA | 2012-09-17 |
| Date Added to Maude | 2012-09-20 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHIC |
| Product Code | IZF |
| Date Received | 2012-09-17 |
| Model Number | DEFINIUM 8000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 8200 WEST TOWER AVE MILWAUKEE WI 53223 US 53223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-17 |