MAUDE Adverse Event Report: CERNER CORPORATION FETALINK; SOFTWARE

Model Number	FETALINK 200.3.0 TO FETALINK 200.5.0
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cerner distributed a flash notification on january 11, 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 or Problem Description
This report documents information related to an issue identified with functionality included in cerner's fetalink¿.This issue involves cerner's fetalink and affects users that utilize fetalink as a diagnostic aid which displays the graphical images of fetal and maternal heart rate and other data that are gathered from the monitoring devices attached to the patient.In cerner millennium, when the user adds an annotation for a fetal monitor that is displayed in the central monitor perspective while the perspective is refreshed, the application may freeze, and new device data may no longer be displayed.When this happens, all device data for the monitored locations in the central monitor perspective are out of date, and new device data, including alerts and notifications, are not displayed.Patient care could be adversely affected, as clinicians may not have access to accurate and up-to-date maternal and fetal monitoring data.This includes fetal waveforms, vital sign containers, alerts, notifications, monitors powered on or off, or a change in monitor association.This could result in patient care delay.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 january 11, 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 flash notification flash21-0013-1 on march 17, 2021 to all potentially impacted client sites.The software notification includes a description of the issue and notice that a software modification has been developed to address the issue for all sites that could potentially be 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 fetalink®.This issue involves cerner's fetalink and affects users that utilize fetalink as a diagnostic aid which displays the graphical images of fetal and maternal heart rate and other data that are gathered from the monitoring devices attached to the patient.In cerner millennium, when the user adds an annotation for a fetal monitor that is displayed in the central monitor perspective while the perspective is refreshed, the application may freeze, and new device data may no longer be displayed.When this happens, all device data for the monitored locations in the central monitor perspective are out of date, and new device data, including alerts and notifications, are not displayed.Patient care could be adversely affected, as clinicians may not have access to accurate and up-to-date maternal and fetal monitoring data.This includes fetal waveforms, vital sign containers, alerts, notifications, monitors powered on or off, or a change in monitor association.This could result in patient care delay.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: FETALINK
• Common Device Name: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 11163635
• Report Number: 1931259-2021-00001
• Device Sequence Number: 11664509
• Product Code: HGM
• UDI-Device Identifier: 00853023006227
• UDI-Public: (01)00853023006227(10)FL200.3.2,(01)00853023006227(10)FL200.4.3,(01)00853023006227(10)FL200.5.0
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K091251
• 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: Notification,Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: FETALINK 200.3.0 TO FETALINK 200.5.0
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1