MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-15 for POWERNOTE - NOT A MEDICAL DEVICE 2015.01 manufactured by Cerner Corporation.
[52608746]
Cerner distributed a priority review flash notification (flash16-0401-0) on (b)(6) 2016 to all potentially impacted client sites. The software notification includes a description of the issue, an alternative workflow and notification that 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
[52608747]
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 malfunctioned associated with this software product. Cerner filing of this medwatch report does not signify cerner belief or understanding that medical device report are required to be filed for cerner's powernote nor is it currently actively regulated by the fda. This report documents information related to an issue identified with functionality included in cerner's millennium powernote. The issue occurs when a powernote document includes a table that contains multiple lines of text within a cell. When these powernotes are rendered in clinical reporting xr or healthelife applications, the documentation captured in the affected cells may not be printed in its entirety. Patient care could be adversely affected, as clinicians could make decisions 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
[63924557]
Cerner distributed a priority review flash notification (flash16-0401-0) on august 8, 2016 to all potentially impacted client sites. The software notification included a description of the issue, an alternative workflow and notification that a software modification was developed to address the issue for all sites that could be potentially impacted. Cerner distributed an updated priority review flash notification (flash16-0401-1) on december 5, 2016 to all potentially impacted client sites. The software notification includes a description of the issue, an alternative to prevent the issue from occurring, 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
[63924558]
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 malfunctioned associated with this sofware product. Cerner filing of this medwatch report does not signify cerner belief or understanding that medical device report are required to be filed for cerner's powernote nor is it currently actively regulated by the fda. This report documents information related to an issue identified with functionality included in cerner's millennium powernote. The issue occurs when a powernote document includes a table that contains multiple lines of text within a cell. When these powernotes are rendered in clinical reporting xr or healthelife applications, the documentation captured in the affected cells may not be printed in its entirety. Patient care could be adversely affected, as clinicians could make decisions 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 | 1931259-2016-00011 |
| MDR Report Key | 5875132 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-15 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-04-19 |
| Date Mfgr Received | 2016-04-19 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2016-08-15 |
| 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 | POWERNOTE - NOT A MEDICAL DEVICE |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2016-08-15 |
| Model Number | 2015.01 |
| 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 ROCKCREEK PARKWAY KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-15 |