FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2092440
·
Received May 2, 2011
Report
- Report Number
- 1720753-2011-06805
- Event Type
- Malfunction
- Date Received
- May 2, 2011
- Date of Event
- April 13, 2011
- Report Date
- May 2, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE DARLINGTON AMPLIFIER TRANSISTORS AND THE GENERATOR DRIVER BOARD WERE REPLACED. THE CUSTOMER REPLACED THE BATTERY. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A PRE-CHARGE FAILURE ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |