FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2170981
·
Received June 30, 2011
Report
- Report Number
- 1720753-2011-08691
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 30, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION AND COULD NOT DUPLICATE THE REPORTED PROBLEM. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM LOCKED UP AND WOULD NOT PERFORM FLUOROSCOPY CORRECTLY. IT WAS ALSO REPORTED THAT THE SYSTEM HAD AN IMAGE QUALITY ISSUE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |