MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-30 for DYNAMIC DOCUMENTATION WITH FOREIGN SYSTEM INTERFACES (FSI) 2012.01 - 2015.01 manufactured by Cerner Corporation.
[71481601]
Cerner distributed a priority review flash notification flash17-0160-0 on march 10, 2017 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.
Patient Sequence No: 1, Text Type: N, H10
[71481602]
This report documents information related to an issue identified with functionality included in cerner's millennium dynamic documentation with foreign system interfaces (fsi). ? The issue involves cerner millennium and affects users that utilize dynamic documentation with foreign system interfaces (fsi).? When the system converts text from html to plain text, documentation may be included from unintended documents if multiple conversion requests are sent to the auto text server at the same time. Patient care could be adversely affected, if clinicians receive incorrect data and make medical decisions based on that information. ? 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 | 1931259-2017-00001 |
| MDR Report Key | 6446049 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-30 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-02-08 |
| Device Manufacturer Date | 2016-01-20 |
| Date Added to Maude | 2017-03-30 |
| 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 ROCKCREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal | 64117 |
| Manufacturer G1 | CERNER CORPORATION |
| Manufacturer Street | 2800 ROCKCREEK 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 | DYNAMIC DOCUMENTATION WITH FOREIGN SYSTEM INTERFACES (FSI) |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2017-03-30 |
| Model Number | 2012.01 - 2015.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERNER CORPORATION |
| Manufacturer Address | 2800 ROCKCREEK PARKWAY KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-30 |