FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2040675
·
Received March 22, 2011
Report
- Report Number
- 9617766-2011-00662
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 22, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE DISPLAY ADAPTER, SINGLE BOARD COMPUTER, AND SYSTEMS' INTERFACE PRINTED CIRCUIT BOARD WERE REPLACED. THE BOOT SETTINGS WERE RESET AND THE HARD DRIVE WAS REFORMATTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP AND ALSO MIXED PT IMAGES. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUROSCOPIC XRAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |