FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2090495
·
Received April 26, 2011
Report
- Report Number
- 9617766-2011-00936
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- March 30, 2011
- Report Date
- April 26, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SINGLE BOARD COMPUTER WAS UPGRADED AND THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WERE NO IMAGES ON THE 8800 SYSTEM. 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 |