Learn how to configure your Vault to support multiple device remedial actions and malfunctions on a Case.
About the Feature
Vault Safety now supports data entry for Remedial Actions and Malfunction at the device-level, as well as device codes for Cases that involve multiple Combination Products or a Combination Product that has multiple device constituents. Case Product Remedial Action and Malfunction can be exported in Medwatch 3500A, FDA E2B(R2), and VAERS E2B(R3) formats.
For details on working with device-specific adverse event codes, see Enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions.
To learn more about working with Remedial Actions and Malfunctions, see Enter Case Data: Case Product Details Section and Enter Case Data: Case Device Details Section.
Update Case Page Layout for Device Report Type (Status)
- Go to Admin > Configuration > Objects > Case > Layouts.
- Select the Case Page Layout.
- In the Device Details section, complete the following setup:
- Add the Device Report Type (Status) field.
- Remove the Remedial Action and Remedial Action-Other fields.
- To rearrange the fields, drag and drop.
- Select Save.
Update Case Product Device Detail Page Layout for Remedial Action and Malfunction
- Go to Admin > Configuration > Objects > Case Product > Layouts.
- Select the Device Detail Page Layout.
- In the Details section, complete the following setup:
- Add the Malfunction field.
- Add the Remedial Action field.
- Add the Remedial Action Other field.
- To rearrange the fields, drag and drop.
- Select Save.
