FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2100404
·
Received May 13, 2011
Report
- Report Number
- 9617766-2011-01044
- Event Type
- Malfunction
- Date Received
- May 13, 2011
- Date of Event
- April 27, 2011
- Report Date
- May 13, 2011
- Manufacturer
- GE MED SYSTEMS (INDIA) PRIVATE LTD.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE MONOBLOCK AND THE HIGH VOLTAGE CABLE ASSEMBLY WERE REPLACED, AND THE FILAMENT WAS CALIBRATED. 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 SYSTEM SHUT DOWN DURING A PROCEDURE. 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. | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |