FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2093114
·
Received May 3, 2011
Report
- Report Number
- 9617766-2011-00986
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- April 8, 2011
- Report Date
- May 3, 2011
- Manufacturer
- GE MED SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FLUORO FUNCTION BOARD WAS REPLACED. 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 FLUOROSCOPY TIMER WOULD COUNT UP ON ITS OWN EVEN THOUGH FLUOROSCOPY WAS NOT BEING PRODUCED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE MED SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |