FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3000983
·
Received February 27, 2013
Report
- Report Number
- 1720753-2013-03173
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- August 8, 2012
- Report Date
- February 27, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE IMAGE PROCESSOR. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING ANGIOGRAPHY, THE SYSTEM WOULD NOT WORK. THE FIELD ENGINEER REPORTED THAT THE IMAGES PRODUCED WERE GRAY AND UNUSABLE. 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 |
|---|---|---|---|---|---|---|---|
| 83919 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |