FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4180956
·
Received October 10, 2014
Report
- Report Number
- 1720753-2014-08515
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 22, 2014
- Report Date
- October 10, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ONSITE INVESTIGATION REVEALED THAT NO CAUSE COULD BE DETERMINED. 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 THE SYSTEM FAILED TO COMMUNICATE THEREBY NECESSITATING A REBOOT TO RESTORE FUNCTIONALITY. IT IS LIKELY THE SYSTEM LOCKED UP. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642821 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |