FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2221815
·
Received June 20, 2011
Report
- Report Number
- 9617766-2011-01267
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 20, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE CABLES FROM THE DISPLAY BOARD WERE CHECKED AND THE DISPLAY BOARD WAS CLEARED AND RECONNECTED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S MONITORS DISPLAYED SNOWY WHITE SCREENS AT BOOT UP. 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 |