FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 3172193
·
Received June 5, 2013
Report
- Report Number
- 1720753-2013-06786
- Event Type
- Malfunction
- Date Received
- June 5, 2013
- Date of Event
- May 21, 2013
- Report Date
- June 5, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED A VIDEO CIRCUIT BOARD. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED: "BLACK SCREEN ON LEFT MONITOR." THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. 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 |
|---|---|---|---|---|---|---|---|
| 249163 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |