FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3874338
·
Received April 18, 2014
Report
- Report Number
- 1720753-2014-03406
- Event Type
- Malfunction
- Date Received
- April 18, 2014
- Date of Event
- March 27, 2014
- Report Date
- April 18, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. THE REPORTED ISSUE WAS NOT DUPLICATED. HOWEVER, THE FE FOUND THAT THE SYSTEM POWER SUPPLY WAS DROPPING BELOW OPTIMUM OPERATING VOLTAGE. THE POWER SUPPLY WAS 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 THAT THE SYSTEM LOCKED UP. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237895 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |