MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-10-04 for CERNER CARETRACKER N/A manufactured by Cerner Corporation.
[89487879]
The only impacted client was notified of the issue on (b)(6) 2017 and the issue was resolved on (b)(6) 2017. Cerner corporation considers the issue resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[89487880]
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 caretracker? Or powerchart ltc? 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 caretracker and powerchart ltc. The issue occurs when fluid intake and output (i/o) observations are documented in powerchart ltc and integrated into caretracker. When the i/o observations are sent from powerchart ltc into caretracker, the timestamp is in utc format rather than the local time where caretracker is located. This could result in the incorrect fluid i/o total amounts for a defined time period displaying in caretracker. Patient care could be adversely affected if treatment decisions are made based on incorrect i/o totals. 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 | 1931259-2017-00004 |
| MDR Report Key | 6914240 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-10-04 |
| Date of Report | 2017-10-04 |
| Date of Event | 1978-07-31 |
| Date Mfgr Received | 2017-07-31 |
| Device Manufacturer Date | 2013-05-22 |
| Date Added to Maude | 2017-10-04 |
| 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 | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERNER CARETRACKER |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2017-10-04 |
| Model Number | N/A |
| 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 | 2017-10-04 |