MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-01 for ELECTRONIC MEDICAL RECORD manufactured by Epic.
[39744921]
Blood cultures were ordered as part of a fever work up. The results were randomly and intermittently electronically transmitted to the ehr data storage library, but there was not any warning or notification that a positive blood culture was reported. More than 24 hours elapsed before any clinician knew and antibiotics started. The delay, commonly caused by silent delivery of life critical results, was life threatening in this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060731 |
| MDR Report Key | 5479532 |
| Date Received | 2016-03-01 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-02-11 |
| Date Added to Maude | 2016-03-04 |
| 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 | ELECTRONIC MEDICAL RECORD |
| Generic Name | MDDS/EHR |
| Product Code | NSX |
| Date Received | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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; 2. Other | 2016-03-01 |