FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2201307
·
Received August 3, 2011
Report
- Report Number
- 1720753-2011-20648
- Event Type
- Malfunction
- Date Received
- August 3, 2011
- Date of Event
- July 20, 2011
- Report Date
- August 3, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CINE ASSOCIATED CONNECTORS WERE RESEATED AND CURRENT SOFTWARE WAS REINSTALLED. THE CINE DRIVE WAS FORMATTED AND CONFIGURED. 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 DISPLAYED AN INTERMITTENT MOTION ERROR WARNING. 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 |