FDA Adverse Event
Malfunction
Summary report: N
OEC 9800
MDR report key: 1613391
·
Received February 11, 2010
Report
- Report Number
- 1720753-2010-00369
- Event Type
- Malfunction
- Date Received
- February 11, 2010
- Date of Event
- January 26, 2010
- Report Date
- February 10, 2010
- Manufacturer
- GE OEC MEDICAL SYSEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYS AND REPLACED THE HIGH VOLTAGE POWER SUPPLY REGULATOR AND THE FILAMENT DRIVER BOARDS, RESEATED CIRCUIT BOARDS, REGREASED AND RESEATED THE HIGH VOLTAGE CONNECTORS, AND PERFORMED A FILAMENT CALIBRATION. SYS OPERATES AS INTENDED. (B) (4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE SYS IS DISPLAYING AN MA SENSOR FAILURE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OEC 9800 | SURGICAL NAVIGATION SYSTEM | JAA | GE OEC MEDICAL SYSEMS INC | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |