FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3882814
·
Received April 10, 2014
Report
- Report Number
- 1720753-2014-03103
- Event Type
- Malfunction
- Date Received
- April 10, 2014
- Date of Event
- March 19, 2014
- Report Date
- April 10, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE CONNECTORS WERE RESEATED 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
IT WAS REPORTED THAT THE SYSTEM HAD INTERMITTENT COMMUNICATION FAILURES PREVENTING THE SYSTEM FROM MAKING EXPOSURES. 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 |
|---|---|---|---|---|---|---|---|
| 216499 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |