Cerner CareAware iBus CareAwareiBus6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853023006012), received between Aug 27, 2021 and Aug 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2021Computer Software Problem; Computer Software Problem

  THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S CAREAWARE IBUS®. THIS ISSUE INVOLVES CERNER'S CAREAWARE IBUS® AND AFFECTS USERS THAT ASSIGN ROLE BASED ALERTING IN CAREAWARE® EVENT MANAGEMENT, WHICH IS USED AS A SECONDARY MECHANISM TO ROUTE EVENT OR ALARM INFORMATION TO MOBILE PHONES OR OTHER COMPUTING OR COMMUNICATIONS ENDPOINTS. IF A PERSONNEL RECORD IS SAVED IN CERNER MILLENNIUM, THAT PERSONNEL RECORD CAN FAIL TO SET AN ORGANIZATION IDENTIFIER IN CAREAWARE EVENT MANAGEMENT DUE TO A DEFECT IN CAREAWARE IBUS. IF ALERTING IS BUILT BASED ON ROLES, THE CLINICIAN MAY NOT BE NOTIFIED APPROPRIATELY OF A SECONDARY ALERT THROUGH CAREAWARE EVENT MANAGEMENT, WHICH COULD LEAD TO A DELAY IN PATIENT CARE. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PATIENT EVENTS AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378114 ↗