FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2041624
·
Received March 24, 2011
Report
- Report Number
- 9617766-2011-00697
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 23, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE DISPLAY ADAPTER, THE SINGLE BOARD COMPUTER, AND THE SYSTEM INTERFACE PCB. THE BIOS WERE RESET AND THE SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 8800 SYSTEM WOULD IMPORT IMAGES FROM OTHER PT FILES. 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 | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |