FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2961677
·
Received February 11, 2013
Report
- Report Number
- 1720753-2013-01623
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 31, 2013
- Report Date
- February 11, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND CLEANED AND LUBRICATED THE HIGH VOLTAGE CONNECTORS. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE TUBE WAS INTERMITTENTLY ARCING, WHICH CAUSED THE SYSTEM TO INTERMITTENTLY LOCK UP. THIS COULD RESULT IN PROCEDURAL DELAYS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60153 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |