FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 4214028
·
Received October 24, 2014
Report
- Report Number
- 1720753-2014-08910
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Date of Event
- October 6, 2014
- Report Date
- October 24, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE PLUGS AND CONNECTORS FROM PS1 WERE EVALUATED AND RESEATED. THE VOLTAGE ON PS1 WAS EVALUATED AND READJUSTED. THE SYSTEM WAS TESTED, FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE IMAGES FROZE DURING FLUORO AND THE C-ARM WOULD REBOOT. THIS CAN CAUSE AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. 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 |
|---|---|---|---|---|---|---|---|
| 678620 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |