FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2062412
·
Received April 12, 2011
Report
- Report Number
- 9617766-2011-00892
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- October 8, 2010
- Report Date
- April 12, 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
NO GE SERVICE WAS PERFORMED. THE FAILURE WAS CLEARED BY THE CUSTOMER. NO FURTHER REPAIR INFORMATION IS AVAILABLE. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE STENOSCOP SYSTEM MADE A CRACKLING NOISE AND SMELLED LIKE IT WAS BURNING. 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 | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |