FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 1993034
·
Received February 8, 2011
Report
- Report Number
- 9617766-2011-00257
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 19, 2011
- Report Date
- February 8, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND DETERMINED THE ON/OFF SWITCH NEEDED TO BE REPLACED. THE GE REPRESENTATIVE IS WAITING FOR CUSTOMER TO PROVIDE ACCESS TO AFFECT REPAIRS.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A SWITCH IS COMING LOOSE DURING PROCEDURES. NO PATIENT 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 |