FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2861665
·
Received November 29, 2012
Report
- Report Number
- 1720753-2012-09861
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 29, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE CAMERA, THE IMAGE INTENSIFIER POWER SUPPLY, AND THE ACCESSORY MICROSWITCH, AND ADJUSTED THE 5 VOL POWER SUPPLY. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WOULD NOT PRODUCE AN IMAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |