FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2103264
·
Received May 17, 2011
Report
- Report Number
- 9617766-2011-01063
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- April 29, 2011
- Report Date
- May 17, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. PARTS WERE ORDERED IN ORDER TO REPAIR THE PROBLEM. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADDITIONAL SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S COLLIMATOR INTERMITTENTLY CLOSED AND NO VISUAL DISPLAY OF THE FLUOROSCOPY IMAGE WAS ACCESSIBLE DESPITE THE LIGHT BEING ON. 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 (GE PRIVATE) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |