MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-15 for CERNER MILLENNIUM POWERCHART, FIRSTNET, AND SURGICAL POWERCHART N/A manufactured by Cerner Corporation.
[102458583]
Cerner distributed a flash notification ((b)(4)) on march 7, 2018 to all potentially impacted client sites. This notification includes a description of the issue, a reminder that the maximum_charts preference be set to 1 (one) and an explanation that the investigation is ongoing to identify the cause of the issue. Cerner corporation will provide a follow-up report when the root cause of the issue is identified and a permanent correction is available.
Patient Sequence No: 1, Text Type: N, H10
[102458584]
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 millennium powerchart? , firstnet? , and surgical powerchart? , 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 millennium emr. If a user has multiple patient charts open at the same time, the active patient chart may change unexpectedly to another open patient chart when the user performs actions in the chart they were originally viewing. The information in the demographics bar, which displays identifying information about the patient such as name, date of birth, allergies, medical record number, etc. Will display the correct demographic information for the now-active patient chart. Also, when multiple patient charts are open, each chart is displayed with a different color background for identifying purposes. This issue can occur if the maximum_charts institution preference is set to a value greater than 1 (one). This preference controls the number of charts that can be open at one time. Cerner's recommendation is to have the maximum_charts preference set to 1, which aligns with the joint commission recommendation. Patient care could be affected if a user takes action for an unintended patient due to another open patient chart displaying unexpectedly. Cerner has received a report of the issue potentially contributing to a clinician administering medication to an incorrect patient. The medication administration may have contributed to this patient's death. This issue is still under investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1931259-2018-00003 |
| MDR Report Key | 7340958 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-15 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2018-02-19 |
| Device Manufacturer Date | 2010-06-25 |
| Date Added to Maude | 2018-03-15 |
| 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 ROCK CREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal | 64117 |
| Manufacturer Phone | 8162011368 |
| Manufacturer G1 | CERNER CORPORATION |
| Manufacturer Street | 2800 ROCK CREEK 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, FIRSTNET, AND SURGICAL POWERCHART |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2018-03-15 |
| 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 ROCK CREEK PARKWAY KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-15 |