FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2041511
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02751
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE GENERATOR INTERFACE BOARD (GIB), THE COIN BATTERY FOR THE GENERATOR INTERFACE BOARD, RESET MEMORY NODES, AND RESEATED CONNECTORS. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A COMMUNICATION ERROR. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |