FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2820414
·
Received October 31, 2012
Report
- Report Number
- 1720753-2012-08940
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 20, 2012
- Report Date
- October 31, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM HAD A COMMUNICATION ERROR AND LOCKED UP DURING A CASE. THE SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PT INJURY OR DEATH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |