MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-06-26 for CERNER MILLENNIUM POWERCHART LTC N/A manufactured by Cerner Corporation.
[48191449]
Cerner distributed a priority review flash notification (b)(4) on june 15, 2016 to all potentially impacted client sites. The software notification includes a description of the issue and notice that a software modification is being developed to address the issue for all sites that could potentially be impacted. ? Cerner corporation will provide a follow-up report when the software modification is available.
Patient Sequence No: 1, Text Type: N, H10
[48191450]
This report documents information related to an issue identified with functionality included in cerner's millennium powerchart ltc nursing documentation. The issue occurs when the nursing documentation downtime mar report is used to administer medications to patients when cerner millennium powerchart ltc is unavailable. In cerner millennium, when the user prints the downtime mar report, suspended medications are included on the report but do not include a note of the "suspended" status. Patient care could be adversely affected, as clinicians may administer suspended medications in error. Cerner has not received communication on any adverse patient events as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
[61009236]
Cerner distributed a priority review flash notification flash16-0291-0 on june 15, 2016 to all potentially impacted client sites. The software notification includes a description of the issue and notice that a software modification is being developed to address the issue for all sites that could potentially be impacted. Cerner distributed an updated flash notification, flash16-0291-1, on november 4, 2016. The software notification includes a description of the issue and notice 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 to be resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[61009237]
This report documents information related to an issue identified with functionality included in cerner's millennium powerchart ltc nursing documentation. The issue occurs when the nursing documentation downtime mar report is used to administer medications to patients when cerner millennium powerchart ltc is unavailable. In cerner millennium, when the user prints the downtime mar report, suspended medications are included on the report but do not include a note of the "suspended" status. Patient care could be adversely affected, as clinicians may administer suspended medications in error. 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 | 1931259-2016-00009 |
| MDR Report Key | 5750278 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-06-26 |
| Date of Report | 2016-06-24 |
| Date of Event | 2016-05-16 |
| Date Mfgr Received | 2016-04-19 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2016-06-26 |
| 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 | CERNER MILLENNIUM POWERCHART LTC |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2016-06-26 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | N/A |
| 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 | 2016-06-26 |