FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3801989
·
Received February 4, 2014
Report
- Report Number
- 1720753-2014-01139
- Event Type
- Malfunction
- Date Received
- February 4, 2014
- Date of Event
- January 20, 2014
- Report Date
- February 4, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP 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 DISPLAYED AN INTERMITTENT CHARGER FAILED ERROR MESSAGE AT BOOT UP. WHEN THIS MESSAGE IS DISPLAYED AT BOOT UP, THE SYSTEM WILL NOT OPERATE. THERE IS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73575 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |