FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2941165
·
Received January 18, 2013
Report
- Report Number
- 1720753-2013-00827
- Event Type
- Malfunction
- Date Received
- January 18, 2013
- Date of Event
- January 10, 2013
- Report Date
- January 18, 2013
- 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 REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE X-RAY TUBE. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE TUBE WAS ARCING, CAUSING A COMMUNICATION FAILURE AND THAT THE SYSTEM WOULD NOT PRODUCT X-RAYS UNTIL IT IS REBOOTED. 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 |
|---|---|---|---|---|---|---|---|
| 28522 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |