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 |