MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-03 for 724ACCESS DOWNTIME VIEWER 724ACCESS DOWNTIME VIEWER TOOLKIT 5.2 (ALL RELEASE manufactured by Cerner Corporation.
[25002815]
Cerner distributed a priority review flash notification on august 24, 2015 to all potentially impacted client sites. The software notification includes a description of the issue, an alternate workflow, and notification that a software modification has been developed to address the issue for all sites that could be potentially impacted. Cerner corporation considers the issue to be resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[25002816]
The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner corporation has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product. Cerner's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for cerner 724access replication management nor are these currently actively regulated by the fda. This report documents information related to an issue identified in cerner retail pharmacy. The issue involves 724access replication management solutions and affects users that utilize the 724access downtime viewer to provide access to clinical data that otherwise could not be accessed or viewed during downtime. In 724access downtime viewer, clinical data could be incomplete on the end users device without any indication. This may occur in rare circumstances during the replication process where the end user device is not processing data at its full capacity. Patient care could be adversely affected, as clinical decisions could be made based on incomplete 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 | 1931259-2015-00006 |
| MDR Report Key | 5054570 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-03 |
| Date of Report | 2015-09-01 |
| Date of Event | 2015-08-07 |
| Date Mfgr Received | 2015-08-07 |
| Date Added to Maude | 2015-09-03 |
| 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 Phone | 8162011368 |
| 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 | 724ACCESS DOWNTIME VIEWER |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2015-09-03 |
| Model Number | 724ACCESS DOWNTIME VIEWER TOOLKIT 5.2 (ALL RELEASE |
| 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 | 2015-09-03 |