FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2081898
·
Received April 5, 2011
Report
- Report Number
- 9617766-2011-00797
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 22, 2011
- Report Date
- April 5, 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 HARD DRIVE WAS REPLACED AND THE SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 8800 SYSTEM PATIENT IMAGE FILE INFORMATION WAS MIXED 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. (GE PRIVATE) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |