MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-29 for CERNER MILLENNIUM CLINICAL REPORTING, DYNAMIC DOCUMENTATION,POWERCHART FRAMEWORK ADMININSTRATION.90 THROUGH 122, SMART TEMPLATE WIZ N/A manufactured by Cerner Corporation.
[109517411]
Cerner distributed a flash notification ((b)(4)) on may 25, 2018 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.
Patient Sequence No: 1, Text Type: N, H10
[109517412]
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 millennium clinical reporting? , dynamic documentation? , or powerchart? , nor are these products currently actively regulated by the fda. This report documents information related to an issue identified with cerner's smart templates wizard intake and output component when utilized in cerner millennium clinical reporting? , dynamic documentation? , and powerchart?. The issue involves cerner millennium cerner millennium clinical reporting? , dynamic documentation? , and powerchart? And affects users that utilize the smart template wizard intake and output component to add the intake and output (i&o) volume into patient documentation. In cerner millennium, when the user's physical location is not in the same time zone as the client's hosted domain, the smart template could include additional volumes or omit volumes from the summarized values that occurred during the time offset between the two time zones. Patient care could be adversely affected if clinical decisions are made based on inaccurate i&o totals in the patient's documentation. Cerner has not received communication on any adverse patient events as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1931259-2018-00008 |
| MDR Report Key | 7549396 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-29 |
| Date of Report | 2018-08-01 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2015-07-09 |
| Date Added to Maude | 2018-05-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHELLEY LOOBY |
| Manufacturer Street | 2800 ROCK CREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal | 64117 |
| Manufacturer Phone | 8162011368 |
| Manufacturer G1 | CERNER CORPORATION |
| Manufacturer Street | 2800 ROCK CREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64117 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERNER MILLENNIUM CLINICAL REPORTING, DYNAMIC DOCUMENTATION,POWERCHART FRAMEWORK |
| Generic Name | SOFTWARE, PRODUCT CODE: LNX |
| Product Code | LNX |
| Date Received | 2018-05-29 |
| Model Number | ADMININSTRATION.90 THROUGH 122, SMART TEMPLATE WIZ |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERNER CORPORATION |
| Manufacturer Address | 2800 ROCK CREEK PARKWAY KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-29 |