FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2092790
·
Received May 5, 2011
Report
- Report Number
- 1720753-2011-06973
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 18, 2011
- Report Date
- May 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND REPLACED THE HIGH VOLTAGE CABLE ASSEMBLY. 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'S HIGH VOLTAGE CABLE HAD A CUT IN THE INSULATION. 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 |