FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2971356
·
Received February 4, 2013
Report
- Report Number
- 1720753-2013-01431
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- October 23, 2012
- Report Date
- February 4, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE EQUIPMENT STOPPED. THE FIELD ENGINEER NOTED THAT THE CUSTOMER STATED THE SYSTEM HAD A COMPLETE LOSS OF FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47392 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |