FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2022219
·
Received February 28, 2011
Report
- Report Number
- 9617766-2011-00486
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- November 8, 2010
- Report Date
- February 28, 2011
- Manufacturer
- GE MEDICAL 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 REP PERFORMED AN ON SITE INVESTIGATION. THE SERVICE REP REPLACED THE HARD DISK DRIVE. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN ERROR MESSAGE WAS DISPLAYING ON THE STENOSCOP SYSTEM. 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 | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |