FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2021882
·
Received February 25, 2011
Report
- Report Number
- 9617766-2011-00462
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 25, 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 REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE BACKPLANE, RESEATED CIRCUIT BOARDS AND CONNECTORS, AND RELOADED SOFTWARE. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED MIXED UP IMAGES. PATIENT IMAGES ARE BEING STORED IN THE WRONG FOLDERS, AND DISPLAYED IMAGES ARE NOT THE IMAGE FROM THE SELECTED THUMBNAIL IMAGE. 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 |