FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 1973656
·
Received January 18, 2011
Report
- Report Number
- 9617766-2011-00083
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- July 8, 2009
- Report Date
- January 18, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THE X-RAY WARNING LAMP CABLE SHORTED TO GROUND. THIS CAUSED THE LEFT MONITOR TO LOSE ITS 24V POWER SUPPLY AND TO NOT DISPLAY AN IMAGE. A GE REPRESENTATIVE REPLACED THE X-RAY WARNING LAMP CABLE. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM SUDDENLY GOES DARK. 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 |