MAUDE Adverse Event Report: EPIC SYSTEMS CORPORATION EPIC EHR; EPIC SOFTWARE TRANSMISSION AND STORAGE

Device Problems Use of Device Problem (1670); Patient Data Problem (3197)

Patient Problem No Information (3190)

Event Date 06/10/2017

Event Type  malfunction  

Event Description

There was a misidentification of the primary and private physician of this case that resulted in pt info and data being sent to the wrong physician, and a delay in it being distributed to the correct care team.Not only is this a hipaa violation, but it delays care upon transition from hospital.The ehr renders it difficult, if not impossible to, correct the error that populates many fields.

• Brand Name: EPIC EHR
• Type of Device: EPIC SOFTWARE TRANSMISSION AND STORAGE
• Manufacturer (Section D): EPIC SYSTEMS CORPORATION; verona WI 53593
• MDR Report Key: 6642848
• MDR Text Key: 77718175
• Report Number: MW5070405
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• 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: 78 YR
• Patient Weight: 74