FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3201381
·
Received June 26, 2013
Report
- Report Number
- 1720753-2013-07627
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- June 17, 2013
- Report Date
- June 26, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND ADJUSTED THE 5 VOLT POWER SUPPLY. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE FIELD ENGINEER REPORTED THAT A COMMUNICATION FAILURE ERROR OCCURRED AND THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY. 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 |
|---|---|---|---|---|---|---|---|
| 291765 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |