FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2086716
·
Received April 29, 2011
Report
- Report Number
- 9617766-2011-00966
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 12, 2001
- Report Date
- April 29, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE SOFTWARE WAS RELOADED AND THE CMOS BATTERY ON THE CENTRAL PROCESSING UNIT PWB WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DID NOT DISPLAY IMAGES. NO PT 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 |