FDA Adverse Event
Summary report: N
RA1000
MDR report key: 1329086
·
Received February 5, 2009
Report
- Report Number
- 3004526608-2009-00005
- Date Received
- February 5, 2009
- Report Date
- February 21, 2008
- Manufacturer
- GE HEALTHCARE INTEGRATED IT SOLUTIONS
- Product Code
- LLZ
- PMA / PMN Number
- K023557
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE IMAGE MARKERS WOULD BE PRESENT ON THESE MIPS IMAGES (REFORMATTED 2D OR 3D IMAGES). THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED. (B)(4).
Description of Event or Problem · 1
MIPS REVERSING, LEFT TO RIGHT, THE LAST SERVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RA1000 | RA1000 | LLZ | GE HEALTHCARE INTEGRATED IT SOLUTIONS | CY WORKSTATION 2B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |