FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2934162
·
Received January 3, 2013
Report
- Report Number
- 1720753-2013-00091
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- December 17, 2012
- Report Date
- January 3, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RESEATED CONNECTORS. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE LEFT MONITOR WAS NOT WORKING. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INSTABILITY TO SEE THE LIVE 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 |
|---|---|---|---|---|---|---|---|
| 4153 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |