FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 1981458
·
Received February 1, 2011
Report
- Report Number
- 9617766-2011-00208
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- January 10, 2011
- Report Date
- February 1, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THAT IF BOOTED UP SEPARATELY, THE WORKSTATION DISPLAYED A HIGH CAPACITY DISK ERROR. GE REPRESENTATIVE REBOOTED THE SYSTEM AND THE SYSTEM OPERATED AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WILL NOT BOOT UP. NO PATIENT 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 |