FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2092780
·
Received May 5, 2011
Report
- Report Number
- 1720753-2011-06965
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 18, 2011
- Report Date
- May 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE RESEATED THE PRINTED CIRCUIT BOARDS, SET TYPE IN THE CONFIGURATION, AND RELOADED THE SOFTWARE AND THE NODES. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY AN IMAGE. NO PATIENT 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 |