FDA Adverse Event
Other
Summary report: N
PACS SERVER
MDR report key: 1813646
·
Received August 19, 2010
Report
- Report Number
- 3004526608-2010-00022
- Event Type
- Other
- Date Received
- August 19, 2010
- Report Date
- July 22, 2010
- Manufacturer
- GE HEALTHCARE
- Product Code
- LLZ
- PMA / PMN Number
- K043415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTS THAT THE SYSTEM DISPLAYS IMAGE, SERIES, STUDY, AND REPORT FOR PATIENT A WHEN THE USER INTENDS TO SELECT PATIENT B FROM A WORKLIST/NAVIGATION DISPLAY LIST/FOLDER. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PACS SERVER | LLZ | GE HEALTHCARE | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |