MAUDE Adverse Event Report: CERNER CORPORATION ANESTHESIA MANAGEMENT; SOFTWARE

Device Problem Installation-Related Problem (2965)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2023

Event Type  malfunction  

Event Description

The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's anesthesia management, nor are these products currently actively regulated by the fda.The issue involves cerner millennium anesthesia management and affects users that utilize the demographics bar to review event codes for the patient.In anesthesia management, if a custom event code is configured to be displayed in the anesthesia demographics bar, and the latest value documented for that event is uncharted for the patient, the uncharted value may still be displayed on the anesthesia demographics bar.Patient care may be affected if clinical decisions are based on incorrect results displayed on the anesthesia demographics bar.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification october 20, 2023 to all potentially impacted client sites.The software notification includes a description of the issue and configuration steps to resolve the issue.Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.

• Brand Name: ANESTHESIA MANAGEMENT
• Type of Device: 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
• MDR Report Key: 18234440
• MDR Text Key: 330559038
• Report Number: 1931259-2023-00016
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1