MAUDE Adverse Event Report: CERNER CORPORATION CAREAWARE IBUS; SOFTWARE

Model Number	CAREAWARE 6.5.0 CAREAWARE IBUS.2021W16 THROUGH CAREAWARE IBUS.2021W30
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cerner distributed a flash notification on august 26, 2021 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification has been developed to address the issue for all sites that could be potentially impacted.Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.
Event or Problem Description
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.

• Brand Name: CAREAWARE IBUS
• Common Device Name: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• MDR Report Key: 12378114
• Report Number: 1931259-2021-00016
• Device Sequence Number: 19134446
• Product Code: DRG
• UDI-Device Identifier: 00853023006012
• UDI-Public: (01)00853023006012(10)CAREAWAREIBUS6.0.5
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K093134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CAREAWARE 6.5.0 CAREAWARE IBUS.2021W16 THROUGH CAREAWARE IBUS.2021W30
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1