FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2043507
·
Received March 28, 2011
Report
- Report Number
- 9617766-2011-00734
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 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
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE CONDUCTED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE CHECKED THE OPERATION OF THE VIDEO CIRCUIT, AND CLEANED THE AMPLIFIER AND THE CAMERA. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SCREEN ON THE STENOSCOP SYSTEM WOULD INTERMITTENTLY GO BLACK. 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 |