FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2093386
·
Received May 4, 2011
Report
- Report Number
- 9617766-2011-00995
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 15, 2011
- Report Date
- May 4, 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 HIGH AND LOW DOSES WERE ADJUSTED ON THE IRIS. THE SYSTEM WAS TESTED AND FOUND TO WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED HAVING TO USE AN INCREASED DOSAGE WHEN PERFORMING X-RAYS ON THE SYSTEM. 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 |