FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3190086
·
Received June 18, 2013
Report
- Report Number
- 1720753-2013-07323
- Event Type
- Malfunction
- Date Received
- June 18, 2013
- Date of Event
- June 12, 2013
- Report Date
- June 19, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE BATTERIES. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED HEARING A POP LIKE NOISE, A BURNING SMELL, AND THE SYSTEM DISPLAYED KV SATURATION FAULT ERROR MESSAGE AND WOULD NO LONGER OPERATE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277163 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |