FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2961610
·
Received February 11, 2013
Report
- Report Number
- 1720753-2013-01637
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- February 4, 2013
- Report Date
- February 11, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE POWER SUPPLY VOLTAGE WAS ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY DISPLAYED CONTROL PANEL AND COMMUNICATION FAIL ERROR MESSAGES. THESE ERROR MESSAGES WILL LIKELY RESULT IN A SYSTEM LOCKUP, NO BOOT, OR SHUT DOWN. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58687 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |