FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2935367
·
Received January 28, 2013
Report
- Report Number
- 1720753-2013-01133
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Date of Event
- January 12, 2013
- Report Date
- January 28, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND PERFORMED A GENERATOR CALIBRATION AND PERFORMED ADJUSTMENTS TO THE SYSTEM. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WOULD INTERMITTENTLY FAIL TO DISPLAY A VISIBLE FLUOROSCOPIC LIVE IMAGE ON THE LEFT MONITOR. THERE IS NO REPORT OF PT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38278 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |