MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM BEDSIDE MEDICAL DEVICE INTERFACES; SOFTWARE

Model Number 2007.19 THROUGH 2018.06

Device Problem Computer Software Problem (1112)

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

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on february 19, 2021 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 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 bedside medical device interfaces¿, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner millennium bedside medical device interfaces¿ that are associated with surginet¿ anesthesia and either powerchart¿ or fetalink¿.The issue affects users that monitor patient vital information or other physiological parameters using surginet anesthesia and either powerchart or fetalink.When a monitor is associated with a current patient in surginet anesthesia without first being disassociated from the previous patient in powerchart or fetalink (for fetal monitors), the monitor data of the current patient is displayed for the previous patient in interactive view and fetalink.If clinicians do not identify and mitigate this issue before accepting the data from the monitor's storage, data for the wrong patient may be saved to the patient's electronic health record, which may adversely affect patient care.Patient care could be adversely affected if clinicians make clinical decisions based on incorrect vital signs or other physiological parameters.Cerner has not received communication on any adverse patient events as a result of this issue.

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 bedside medical device interfaces®, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner millennium bedside medical device interfaces® that are associated with surginet® anesthesia and either powerchart® or fetalink®.The issue affects users that monitor patient vital information or other physiological parameters using surginet anesthesia and either powerchart or fetalink.When a monitor is associated with a current patient in surginet anesthesia without first being disassociated from the previous patient in powerchart or fetalink (for fetal monitors), the monitor data of the current patient is displayed for the previous patient in interactive view and fetalink.If clinicians do not identify and mitigate this issue before accepting the data from the monitor's storage, data for the wrong patient may be saved to the patient's electronic health record, which may adversely affect patient care.Patient care could be adversely affected if clinicians make clinical decisions based on incorrect vital signs or other physiological parameters.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on february 5, 2021 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 distributed a revised flash notification august 9, 2021 to all potentially impacted client sites.The software notification includes a description of the issue and indicates that software modification has been released 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.

• Brand Name: CERNER MILLENNIUM BEDSIDE MEDICAL DEVICE INTERFACES
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• MDR Report Key: 11362107
• MDR Text Key: 233049654
• Report Number: 1931259-2021-00005
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2007.19 THROUGH 2018.06
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1