FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2100818
·
Received May 12, 2011
Report
- Report Number
- 1720753-2011-07286
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 12, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION AND COULD NOT DUPLICATE THE REPORTED PROBLEM. THE LEMO CONNECTOR BACKSHELL WAS REPAIRED. 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 THAT THE SYSTEM WOULD INTERMITTENTLY NOT BOOT UP COMPLETELY. THIS HAPPENED OUTSIDE OF A CASE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |