FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2023521
·
Received March 1, 2011
Report
- Report Number
- 9617766-2011-00495
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- December 6, 2010
- Report Date
- March 1, 2011
- Manufacturer
- GE MED SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE TOUCH SCREEN. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE TOUCH SCREEN ON THE 8800 SYSTEM WAS NOT WORKING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE MED SYSTEMS (INDIA) PRIVATE LTD | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |