MAUDE Adverse Event Report: EPIC EPIC CPOE AND MDDS DEVICE

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2017

Event Type  malfunction  

Event Description

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.

• Brand Name: EPIC CPOE AND MDDS DEVICE
• Type of Device: EPIC CPOE AND MDDS DEVICE
• Manufacturer (Section D): EPIC; verona WI 53593
• MDR Report Key: 6857682
• MDR Text Key: 85949907
• Report Number: MW5072105
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 86