FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3822754
·
Received February 7, 2014
Report
- Report Number
- 1720753-2014-01267
- Event Type
- Malfunction
- Date Received
- February 7, 2014
- Date of Event
- January 28, 2014
- Report Date
- February 7, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE VOLTAGE ON PS1 POWER SUPPLY WAS FOUND TO BE LOW AND WAS ADJUSTED TO OPTIMUM OPERATING VOLTAGE. 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 WAS UNABLE TO PERFORM FLUOROSCOPY. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TOT HIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80847 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |