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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELECTROCARDIOGRAM

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ELECTROCARDIOGRAM Back to Search Results
Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2015
Event Type  Malfunction  
Event Description

Ecg error for missing/incomplete/incorrect secondary id #. Team member failed to follow and demonstrate procedure instructions as stated in policy #3040 12 lead electrocardiogram (ecg).

 
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Type of DeviceELECTROCARDIOGRAM
MDR Report Key4942094
MDR Text Key6038260
Report Number4942094
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 07/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/02/2015
Event Location Hospital
Date Report TO Manufacturer07/27/2015

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