GE DEFINIUM 8000 *

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number2753159
MDR Report Key2753159
Date Received2012-09-17
Date of Report2012-09-17
Date of Event2012-08-20
Report Date2012-09-17
Date Reported to FDA2012-09-17
Date Added to Maude2012-09-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameGE
Generic NameSYSTEM, X-RAY, TOMOGRAPHIC
Product CodeIZF
Date Received2012-09-17
Model NumberDEFINIUM 8000
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Age5 YR
Device Sequence No1
Device Event Key0
ManufacturerGE HEALTHCARE
Manufacturer Address8200 WEST TOWER AVE MILWAUKEE WI 53223 US 53223


Patients

Patient NumberTreatmentOutcomeDate
10 2012-09-17

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