MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-10-18 for CERNER POWERCHART LTC N/A manufactured by Cerner Corporation.
[90587459]
Cerner notified all potentially impacted clients on october 4-6, 2017. This notification includes a description of the issue, alternative workflows and explanation that a software modification will be developed to address the issue for all sites that are potentially impacted. Cerner corporation will provide a follow-up report when the software modification is available.
Patient Sequence No: 1, Text Type: N, H10
[90587460]
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 caretracker and integrated into powerchart ltc. The i/o observations which are sent from caretracker into powerchart ltc are not being included in the i/o totals in powerchart ltc. Patient care could be adversely affected if treatment decisions are made based on incorrect i/o totals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1931259-2017-00005 |
| MDR Report Key | 6959378 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-10-18 |
| Date of Report | 2018-03-20 |
| Date of Event | 2013-12-16 |
| Date Mfgr Received | 2013-12-16 |
| Device Manufacturer Date | 2013-12-16 |
| Date Added to Maude | 2017-10-18 |
| 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 POWERCHART LTC |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2017-10-18 |
| 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 | 2017-10-18 |