FDA Adverse Event
Malfunction
Summary report: N
MOSAIQ
MDR report key: 3190710
·
Received June 24, 2013
Report
- Report Number
- 2950347-2013-00003
- Event Type
- Malfunction
- Date Received
- June 24, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 24, 2013
- Manufacturer
- IMPAC MEDICAL SYSTEMS, INC.
- Product Code
- IYE
- PMA / PMN Number
- K123230
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER A USER ACCESSES THE ECHART NAVIGATOR WINDOW AND CLICKS THE "QCL" BUTTON, THE PT QUALITY CHECK LIST GRID IS DISPLAYED FOR THAT PT. WHEN THE USER LEAVES THAT PT QUALITY CHECK LIST GRID OPENED, A SELECTS A DIFFERENT PT FROM ANOTHER QUALITY CHECK LIST GRID, E.G. STAFF QUALITY CHECK LIST GRID, THE ECHART NAVIGATOR WINDOW IS NOT DISPLAYING THAT NEWLY SELECTED PT'S NAME. THERE WAS NO PT INVOLVED AT THE TIME OF THE EVENT. NO FURTHER INFO WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286514 | MOSAIQ | ONCOLOGY INFORMATION SYSTEM (IYE) | IYE | IMPAC MEDICAL SYSTEMS, INC. | 2.50.05D7 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |