FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3963030
·
Received June 23, 2014
Report
- Report Number
- 1720753-2014-05334
- Event Type
- Malfunction
- Date Received
- June 23, 2014
- Date of Event
- June 6, 2014
- Report Date
- June 20, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE HEAT SENSOR ON THE INTERCONNECT CABLE WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED 3/4 OF THE FLUOROSCOPIC IMAGE WAS BLACK EFFECTIVELY ELIMINATING THE ABILITY TO VIEW A USABLE IMAGE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 366264 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |