FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 4122075
·
Received September 19, 2014
Report
- Report Number
- 1720753-2014-08033
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Date of Event
- September 3, 2014
- Report Date
- September 19, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE POWER SUPPLY AND BACKPLANE POWER CONNECTORS WERE EVALUATED AND REPLACED. 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 THE SYSTEM SHUTS DOWN UNCOMMANDED. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. 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 |
|---|---|---|---|---|---|---|---|
| 583364 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |