MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-08-14 for REGISTRATION MANAGEMENT, SCHEDULING MANAGEMENT 2015.01 - 2018.01 N/A manufactured by Cerner Corporation.
[82998727]
Cerner distributed a flash notification flash17-0482-0 on august 14, 2017 to all potentially impacted client sites. The software notification includes a description of the issue and notification that a software modification has been developed and is available to address the issue for all sites that could be potentially impacted. Cerner corporation considers the issue resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[82998728]
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 registration management? Or scheduling management? 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 registration management and scheduling management. The issue occurs when patients are combined in the application after completing the scheduling workflow. Patient demographic data may be lost if an error occurs during the combination because the combination fails, and the registration data is lost; however, the combined-away patient is inactivated in the database as expected. Patient care could be adversely affected if treatment decisions are made based on incomplete patient data. 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 | 1931259-2017-00003 |
| MDR Report Key | 6792664 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-01-10 |
| Device Manufacturer Date | 2017-01-04 |
| Date Added to Maude | 2017-08-14 |
| 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 | REGISTRATION MANAGEMENT, SCHEDULING MANAGEMENT |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2017-08-14 |
| Model Number | 2015.01 - 2018.01 |
| 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 | 2017-08-14 |