MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for EPIC CPOE manufactured by Epic.
[87481582]
Innumerable orders are not being received by the intended recipient and ancillary service, resulting in failure to complete disease critical tests and treatments. Care is delayed, hospitalizations are prolonged, diseases are worsening, and patients are at high risk. The ehr device is defective in that there is not any reconciliation mechanism to alert users as to what has not been done as ordered. One patient. One record. One tea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072424 |
| MDR Report Key | 6893975 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-24 |
| Date of Event | 2017-09-14 |
| Date Added to Maude | 2017-09-26 |
| 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 |
| Generic Name | COMPUTERIZED PHYSICIAN ORDER ENTRY |
| Product Code | NSX |
| Date Received | 2017-09-25 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPIC |
| Manufacturer Address | VERONA WI 53593 US 53593 |
| Brand Name | MDDS DEVICE |
| Generic Name | MEDICAL DEVICE DATA SYSTEM |
| Product Code | NSX |
| Date Received | 2017-09-25 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | EPIC |
| Manufacturer Address | VERONA WI 53593 US 53593 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2017-09-25 |