FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2023084
·
Received February 24, 2011
Report
- Report Number
- 9617766-2011-00443
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- January 26, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED PROBLEM. THE SYSTEM OPERATES AS INTENDED. THE GE REP CHECKED CABLES AND CONNECTORS FOR CONNECTION PROBLEMS AS A PRECAUTIONARY MEASURE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE KEYBOARD DOESN'T WORK AND THE LEFT MONITOR HAS A WHITE BAND ACROSS THE DISPLAY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STENOSCOP | FLUOROSCOPY X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |