FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 3014238
·
Received March 6, 2013
Report
- Report Number
- 1720753-2013-03486
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 6, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- 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.
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 CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY SHUT DOWN. THIS WOULD RESULT IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE PROCEDURAL DELAYS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96441 | 6600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |