MAUDE Adverse Event Report: EPIC MYCHART; CPOE/EHR

Device Problems Use of Incorrect Control/Treatment Settings (1126); Programming Issue (3014)

Patient Problem Overdose (1988)

Event Date 05/12/2015

Event Type  Injury  

Event Description

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.

• Brand Name: MYCHART
• Type of Device: CPOE/EHR
• Manufacturer (Section D): EPIC; verona WI 53593
• MDR Report Key: 4834775
• MDR Text Key: 5908332
• Report Number: MW5042999
• Device Sequence Number: 1
• Product Code: MMH
• 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: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Weight: 67