FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2102114
·
Received May 19, 2011
Report
- Report Number
- 1720753-2011-07431
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 19, 2011
- 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 SERVICE REPRESENTATIVE RETRIEVED THE ERROR LOG FILES AND REPLACED THE MONOBLOCK AND THE HIGH VOLTAGE CABLE AS WELL AS THE HIGH VOLTAGE POWER SUPPLY. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD PRODUCE AN ALARM SAYING DO NOT USE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |