FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2102184
·
Received May 19, 2011
Report
- Report Number
- 9617766-2011-01088
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 1, 2011
- Report Date
- May 19, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD. (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE HARD DISK DRIVE WAS REPLACED AND THE KEYBOARD AND DRIVER WERE CONFIGURED, AND THE MDA MEMORY WAS CHECKED. A PART WAS ORDERED AND NEEDS TO BE FOLLOWED UP. NO ADD'L SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S TOUCH SCREEN KEYBOARD WOULD NOT WORK AND THE HARD DISK WAS CAUSING THE PROBLEM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD. (GE PRIVATE) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |