FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 3000967
·
Received February 27, 2013
Report
- Report Number
- 1720753-2013-03205
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 20, 2013
- Report Date
- February 27, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE POWER CORD AND THE LEFT MONITOR WERE REPLACED. THE SYSTEM WAS THEN FOUND TO OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE LEFT (LIVE) MONITOR WAS NOT WORKING. THIS RESULTED IN A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84130 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |