MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-05 for CERNER MILLENNIUM REGISTRATION MANAGEMENT 2007.19-2018.01 N/A manufactured by Cerner Corporation.
[123958560]
Cerner distributed a flash notification on october 1, 2018 to all potentially impacted client sites. The software notification includes a description of the issue and a software modification has been developed to address the issue for all sites that could be potentially impacted. Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[123958561]
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 registration 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 millennium registration management?. The issue involves cerner millennium registration management and occurs when users add a subscriber relationship of self to a patient that was registered in a different time zone. The patient's birth date and birth times displayed in the patient chart may be offset by the number of hours between the two time zones. Patient care could be adversely affected if treatment decisions are based on incorrect time of birth for an infant. Patient care could also be delayed if a user searches for patients by birth date and, if the patient cannot be located, create a duplicate record for the patient. 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 | 1931259-2018-00011 |
| MDR Report Key | 7939948 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-05 |
| Date of Event | 2017-10-06 |
| Date Mfgr Received | 2017-10-06 |
| Device Manufacturer Date | 2009-07-03 |
| Date Added to Maude | 2018-10-05 |
| 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 REGISTRATION MANAGEMENT |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2018-10-05 |
| Model Number | 2007.19-2018.01 |
| 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 ROCK CREEK PARKWAY KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-05 |