Enable Remedial Actions and Malfunction for Combination Products

Learn how to configure your vault to support multiple device remedial actions and malfunctions on a Case.

Note Beginning with 24R1 in April 2024 and for all subsequent releases, Vault Safety General Release Help content is moving to a new site. Test the new site using Limited Release content.

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)

  1. Go to Admin > Configuration > Objects > Case > Page Layouts.
  2. Select the Case Page Layout.
  3. 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.
  4. To rearrange the fields, drag and drop.
  5. Select Save.
Device Report Type (Status) on the Case Product Page Layout
Device Report Type (Status) on the Case Product Page Layout

Update Case Product Device Detail Page Layout for Remedial Action and Malfunction

  1. Go to Admin > Configuration > Objects > Case Product > Page Layouts.
  2. Select the Device Detail Page Layout.
  3. In the Details section, complete the following setup:
    • Add the Malfunction field.
    • Add the Remedial Action field.
    • Add the Remedial Action Other field.
  4. To rearrange the fields, drag and drop.
  5. Select Save.
Case Product Detail Page Layout
Case Product Detail Page Layout

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