FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 3171928
·
Received June 7, 2013
Report
- Report Number
- 1720753-2013-06865
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- May 13, 2013
- Report Date
- June 7, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE LEMO CONNECTOR. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM WOULD NOT DISPLAY A FLUOROSCOPY IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253938 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |