MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-12 for EPIC CPOE AND MDDS DEVICE manufactured by Epic.
[85949907]
User unfriendly ordering device causing errors of many types. In this case, the wrong patient's blood results were listed. This almost resulted in an unnecessary blood transfusion and other interventions. The details as to the mechanism of the error are unknown, but likely a malfunction of the transmission component of the device or an mdds failure. One patient, one record, one tea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072105 |
| MDR Report Key | 6857682 |
| Date Received | 2017-09-12 |
| Date of Report | 2017-09-09 |
| Date of Event | 2017-09-08 |
| Date Added to Maude | 2017-09-12 |
| 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 | EPIC CPOE AND MDDS DEVICE |
| Generic Name | EPIC CPOE AND MDDS DEVICE |
| Product Code | MMH |
| Date Received | 2017-09-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPIC |
| Manufacturer Address | VERONA WI 53593 US 53593 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-12 |