FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 4180651
·
Received October 15, 2014
Report
- Report Number
- 1720753-2014-08663
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 27, 2014
- Report Date
- October 15, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. THE IN HOUSE BIOMED REFORMATTED THE CINE DRIVE. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED. THE SYSTEM WAS PUT BACK INTO SERVICE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654781 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |