FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 1981463
·
Received February 1, 2011
Report
- Report Number
- 9617766-2011-00213
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- January 13, 2011
- Report Date
- February 1, 2011
- Manufacturer
- GE MED SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RESET THE BIOS MEMORY CONFIGURATION, REPLACED THE BATTERY ON THE MONOBLOCK CONTROLLER CARD, ADJUSTED POWER SUPPLY VOLTAGES, AND REPLACED THE BATTERY PACKS. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT 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 MED SYSTEMS (INDIA) PRIVATE LTD | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |