FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2093115
·
Received May 3, 2011
Report
- Report Number
- 9617766-2011-00984
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- October 19, 2010
- Report Date
- May 3, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. A BEAM ALIGNMENT WAS PERFORMED TO BRING THE IMAGE TO IRRADIATED FIELD RATIO INTO TOLERANCE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MINOR NONCOMPLIANCE FIELDS COVERED THE VISUALIZED FIELDS 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 |