FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2022218
·
Received February 28, 2011
Report
- Report Number
- 9617766-2011-00487
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- November 18, 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 A CONNECTOR. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE STENOSCOP SYSTEM WILL INTERMITTENTLY FAIL TO BOOT UP. 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 |