MAUDE Adverse Event Report: CERNER CORPORATION POWERCHART LTC; SOFTWARE

Model Number DOWNTIME MAR VERSIONS 5-7

Device Problem Patient Data Problem (3197)

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

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on (b)(6) 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 powerchart ltc¿, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's millennium powerchart ltc¿ downtime medication administration record (mar).The issue affects users that utilize the downtime mar to administer medication during a downtime event.In cerner millennium, when the downtime mar report is generated nightly for each resident in the long term care facility, the allergies from the first resident in the report are displayed for all residents that follow.Patient care could be adversely affected, as clinicians reference may reference inaccurate allergy information when administering medication.This issue could result in serious injury due to potential allergic reaction.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 powerchart ltc¿, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's millennium powerchart ltc¿ downtime medication administration record (mar).The issue affects users that utilize the downtime mar to administer medication during a downtime event.In cerner millennium, when the downtime mar report is generated nightly for each resident in the long term care facility, the allergies from the first resident in the report are displayed for all residents that follow.Patient care could be adversely affected, as clinicians may reference inaccurate allergy information when administering medication.This issue could result in serious injury due to potential allergic reaction.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on november 1, 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 follow-up flash notification on february 24, 2022, to all potentially impacted client sites.The software notification includes a description of the issue, and notification that 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.

• Brand Name: POWERCHART LTC
• 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: shelley looby ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 12750562
• MDR Text Key: 280098528
• Report Number: 1931259-2021-00019
• 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,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DOWNTIME MAR VERSIONS 5-7
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2018
• 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