MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-04-11 for CAREAWARE ALERTLINK RELEASES 5.2 & 6.0 N/A manufactured by Cerner Corporation.
[42383429]
Cerner distributed a priority review flash notification (b)(4) on april 8, 2016 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 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
[42383430]
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 careaware alertlink, nor are these products currently actively regulated by the fda. This report documents information related to an issue identified in cerner's millennium careaware alertlink. This solution provides secondary notification of alerts from medical devices or nurse call systems directly to a clinician's mobile device. The issue occurs when a provider has a device permanently assigned to them. If no notification is sent to the device for more than 24 hours, the provider is removed from the system cache. When the provider returns for another shift, notifications are not sent as expected, because careaware alertlink assumes that the provider's device is not active. Patient care could be adversely affected if the provider did not receive the secondary alert to their device and did not respond to the primary alerting system. 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 | 1931259-2016-00006 |
| MDR Report Key | 5568199 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-04-11 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-02-25 |
| Date Mfgr Received | 2016-02-25 |
| Device Manufacturer Date | 2015-11-18 |
| Date Added to Maude | 2016-04-11 |
| 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 | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREAWARE ALERTLINK |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2016-04-11 |
| Model Number | RELEASES 5.2 & 6.0 |
| Catalog Number | N/A |
| Lot Number | N/A |
| 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 | 2016-04-11 |