FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4110594
·
Received September 16, 2014
Report
- Report Number
- 1720753-2014-07921
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- August 20, 2014
- Report Date
- September 16, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SOFTWARE UPGRADE WAS INSTALLED DURING THE SERVICE CALL. 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 INTERMITTENT COMMUNICATION FAILURES AND THE SYSTEM HAD TO BE REBOOTED WHENEVER THIS ISSUE OCCURRED. THIS RESULTED IN AN INTERMITTENT LOSS OF IMAGING FUNCTIONALITY. 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 |
|---|---|---|---|---|---|---|---|
| 571760 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |