FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2101632
·
Received May 11, 2011
Report
- Report Number
- 1720753-2011-07212
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 27, 2011
- Report Date
- May 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS 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 THAT THERE WAS A CUT IN THE HIGH-VOLTAGE CABLE OF THE SYSTEM. THIS OCCURRED OUTSIDE OF A PROCEDURE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |