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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 Problem Device Alarm System (1012)
Patient Problem Irregular Pulse (2469)
Event Date 04/25/2015
Event Type  Malfunction  
Event Description

A patient had a long heart pause of 6 seconds, the monitor technician did not call for this. When the rn called to find out why he did not call, the tech said that the alarms did not go off.

 
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Type of DeviceELECTROCARDIOGRAM
MDR Report Key4973095
MDR Text Key6336675
Report Number4973095
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 06/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/19/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NOT APPLICABLE
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/19/2015
Event Location Hospital
Date Report TO Manufacturer08/05/2015
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