FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2062385
·
Received April 12, 2011
Report
- Report Number
- 9617766-2011-00896
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- December 9, 2010
- Report Date
- April 12, 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
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE DOSE WAS ADJUSTED TO SPECIFICATIONS. THE SYSTEM OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DOSE WAS OUT OF TOLERANCE ON THE STENOSCOP SYSTEM. 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 (GE PRIVATE) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |