FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2210587
·
Received August 8, 2011
Report
- Report Number
- 1720753-2011-20781
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- July 27, 2011
- Report Date
- August 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SERVICE REP REPLACED THE IMAGE PROCESSOR. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD LOSE THE IMAGES PRODUCED. 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 |