MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-23 for SOARIAN manufactured by Siemens/cerner.
[41335587]
With the work flow controlled by the electronic care record system, vital sign data is out of sight, tucked away is a silo that requires multiple clicks and time to access. Consequently, the key data of vital signs is out of sight, and thus, out of mind. No one knows the pt data, yet medications are administered resulting in complications because of the inappropriate (for the pt's vital signs) administration of therapies. In this particular case, the pt was hypotensive and received add'l blood pressure lowering medication resulting in critical condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061263 |
| MDR Report Key | 5528946 |
| Date Received | 2016-03-23 |
| Date of Report | 2016-03-26 |
| Date of Event | 2016-03-11 |
| Date Added to Maude | 2016-03-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SOARIAN |
| Generic Name | CPOE/EHR |
| Product Code | LNX |
| Date Received | 2016-03-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS/CERNER |
| Manufacturer Address | KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2016-03-23 |