FDA Adverse Event
Summary report: N
PACS
MDR report key: 1329078
·
Received February 5, 2009
Report
- Report Number
- 3004526608-2009-00003
- Date Received
- February 5, 2009
- Report Date
- October 6, 2008
- Manufacturer
- GE HEALTHCARE INTEGRATED IT SOLUTIONS
- Product Code
- LLZ
- PMA / PMN Number
- K043415
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING SUBMITTED LATE AS THIS IS PART OF OUR ONGOING QUALITY IMPROVEMENT ACTIVITIES. WE HAVE UPDATED THE RISK ASSESSMENT CONTROL RECORD AND THE UPDATE HAS RESULTED IN THE ASSESSMENT THAT THESE REPORTED COMPLAINTS MEET THE REPORTABILITY CRITERIA AS OUTLINED IN THE RISK ASSESSMENT CONTROL RECORD FOR GE HEALTHCARE. FOR THIS REPORT, STEPS OR DATA MAY BE OUT OF SEQUENCE BUT IT IS EVIDENT TO THE USER (EASILY VISIBLE OR ACCESSIBLE). THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE COMPLETE SERIES HAVE FLIPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PACS | PACS SERVER | LLZ | GE HEALTHCARE INTEGRATED IT SOLUTIONS | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |