FDA Adverse Event
Malfunction
Summary report: N
MOSAIQ
MDR report key: 3994784
·
Received June 13, 2014
Report
- Report Number
- 2950347-2014-00023
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Report Date
- June 13, 2014
- Manufacturer
- IMPAC MEDICAL SYSTEMS, INC.
- Product Code
- IYE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MOSAIQ VERSION 2.41.01J0SP2.
Description of Event or Problem · 1
IT WAS REPORTED THAT RESULT PT B'S NAME IS IN THE UPPER RIGHT CORNER AND ON THE TITLE BAR OF THE MAR, BUT THE DRUGS LISTED IN MAR ARE FROM PT A. WHEN USER CANCELS MAR, PT A'S NAME IS DISPLAYED ON THE TITLE BAR OF THE FLOW SHEET WITH PT B'S NAME STILL IN THE UPPER RIGHT CORNER. THERE WAS NO ACTUAL MISTREATMENT REPORTED AS A RESULT OF THIS ISSUE BASED ON THE AVAILABLE INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350751 | MOSAIQ | MOSAIQ ONCOLOGY INFO SYSTEM | IYE | IMPAC MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |