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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC ELI 250A ELECTROCARDIOGRAPH

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MORTARA INSTRUMENT, INC ELI 250A ELECTROCARDIOGRAPH Back to Search Results
Model Number 250A
Device Problem Electromagnetic Interference (1194)
Patient Problem No Information (3190)
Event Date 09/01/2015
Event Type  Malfunction  
Event Description

Upon obtaining a 12 lead ekg, excessive interference with tracing occurs causing some leads to be unreadable. (this has happened intermittently over 6 months. ) other devices in use during the event include telemetry, pulse oximetry, etc. However, the event has happened numerous times and the cause cannot be determined.

 
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Brand NameELI 250A
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
MORTARA INSTRUMENT, INC
7865 north 86th street
milwaukee WI 53224
MDR Report Key5093879
MDR Text Key26412743
Report Number5093879
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/15/2015,09/16/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/22/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/15/2015
Device Age3 yr
Event Location Hospital
Date Report TO Manufacturer09/15/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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