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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIC EPIC CPOE AND MDDS DEVICE

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EPIC EPIC CPOE AND MDDS DEVICE Back to Search Results
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.

 
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Brand NameEPIC CPOE AND MDDS DEVICE
Type of DeviceEPIC CPOE AND MDDS DEVICE
Manufacturer (Section D)
EPIC
verona WI 53593
MDR Report Key6857682
MDR Text Key85949907
Report NumberMW5072105
Device Sequence Number1
Product Code MMH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received09/12/2017
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 the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/12/2017 Patient Sequence Number: 1
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