MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-04 for MYCHART manufactured by Epic.
[5908332]
When entering a weight for dosing medication, the device does not specify the units ie kg for weight entry. Innumerable health care professionals entered the weight in pounds resulting in potential overdoses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042999 |
| MDR Report Key | 4834775 |
| Date Received | 2015-06-04 |
| Date of Report | 2015-06-04 |
| Date of Event | 2015-05-12 |
| Date Added to Maude | 2015-06-11 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYCHART |
| Generic Name | CPOE/EHR |
| Product Code | MMH |
| Date Received | 2015-06-04 |
| Operator | HEALTH PROFESSIONAL |
| 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. Life Threatening | 2015-06-04 |