FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2092464
·
Received May 2, 2011
Report
- Report Number
- 9617766-2011-00981
- Event Type
- Malfunction
- Date Received
- May 2, 2011
- Date of Event
- April 12, 2011
- Report Date
- May 2, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE NODES WERE FLASHED, THE GENERATOR INTERFACE BOARD AND THE FLUORO FUNCTIONS PRINTED CIRCUIT BOARD WERE REPLACED, AND CALIBRATION FILES WERE UPLOADED. THE SYSTEM WAS TESTED AND WAS FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED GENERATOR AND POTENTIOMETER ERROR MESSAGES. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |