FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3823922
·
Received February 21, 2014
Report
- Report Number
- 1720753-2014-01717
- Event Type
- Malfunction
- Date Received
- February 21, 2014
- Date of Event
- February 6, 2014
- Report Date
- February 21, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE VOLTAGE OF POWER SUPPLY NEAR CONTROL PANEL PROCESSOR BOARD WAS EVALUATED AND ADJUSTED TO OPTIMUM OPERATING VOLTAGE. THE POWER SUPPLY CONNECTOR WAS RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM HAD A CONTROL PANEL ERROR. THIS ERROR CAUSES THE SYSTEM TO IMMEDIATELY SHUT DOWN. 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 |
|---|---|---|---|---|---|---|---|
| 109594 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |