MAUDE Adverse Event Report: CERNER CORPORATION CERNER SKYVUE; SOFTWARE

Model Number	CERNER SKYVUE 4.9.2 THROUGH 4.9.3
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report documents information related to an issue identified with functionality included in cerner's millennium skyvue®.The issue affects users that have the annotation tracking preference turned on and utilize skyvue for multiplanar reconstruction (mpr) to visualize medical images.If an mpr fails to save while the user clears the patient data, the previous patient studies may be displayed when a new patient is selected for interpretation.When this occurs, the medical record number and images for each patient are correctly displayed on each image.Patient care could be adversely affected if clinicians review an incorrect patient study and clinical decisions are made based on incorrect information.Patient care could be delayed as clinicians must exit the application and log back in to retrieve the correct study.Cerner has not received communication on any adverse patient events as a result of this issue.
Additional Manufacturer Narrative
Cerner distributed a flash notification on december 14, 2022 to all potentially impacted client sites.The software notification includes a description of the issue, and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner corporation will provide a follow-up report when the software modification is available.
Event or Problem Description
This report documents information related to an issue identified with functionality included in cerner's millennium skyvue®.The issue affects users that have the annotation tracking preference turned on and utilize skyvue for multiplanar reconstruction (mpr) to visualize medical images.If an mpr fails to save while the user clears the patient data, the previous patient studies may be displayed when a new patient is selected for interpretation.When this occurs, the medical record number and images for each patient are correctly displayed on each image.Patient care could be adversely affected if clinicians review an incorrect patient study and clinical decisions are made based on incorrect information.Patient care could be delayed as clinicians must exit the application and log back in to retrieve the correct study.Cerner has not received communication on any adverse patient events as a result of this issue.
Additional Manufacturer Narrative
Cerner distributed a flash notification on (b)(6) 2023 to all potentially impacted client sites.The software notification includes a description of the issue, and a software modification is being 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.Cerner distributed a flash notification on (b)(6) 2022 to all potentially impacted client sites.The software notification includes a description of the issue, and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner corporation will provide a follow-up report when the software modification is available.

• Brand Name: CERNER SKYVUE
• Common Device Name: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer (Section G): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer Contact: jeff mauzey ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 15987622
• Report Number: 1931259-2022-00011
• Device Sequence Number: 17664648
• Product Code: LLZ
• UDI-Device Identifier: 00853023006074
• UDI-Public: (01)00853023006074(10)SV4.9.2,(01)00853023006074(10)SV4.9.3
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K070394
• 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,Followup
• Report Date (Section B): 05/04/2023

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
• Device Model Number: CERNER SKYVUE 4.9.2 THROUGH 4.9.3
• Device Catalogue Number: 10001100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown