FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3063559
·
Received April 12, 2013
Report
- Report Number
- 1720753-2013-04911
- Event Type
- Malfunction
- Date Received
- April 12, 2013
- Date of Event
- April 3, 2013
- Report Date
- April 12, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS REPAIR INFO WAS NOT REPORTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A BURNING SMELL WHILE USING THE C-ARM AND AN OVERLOAD FAULT ERROR MESSAGE WAS DISPLAYED. THIS ERROR MAY CAUSE THE SYSTEM TO SHUT DOWN. 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 |
|---|---|---|---|---|---|---|---|
| 159175 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |