FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3001843
·
Received February 12, 2013
Report
- Report Number
- 1720753-2013-01684
- Event Type
- Malfunction
- Date Received
- February 12, 2013
- Date of Event
- January 31, 2013
- Report Date
- February 12, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED AND THE HIGH VOLTAGE CABLE WAS CLEANED AND REGREASED DURING THE SERVICE CALL. THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A GENERATOR ERROR AND A CONTROLLER ERROR AND THE SYSTEM AUTOMATICALLY SHUTS DOWN WHEN THIS OCCURS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61356 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |