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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC. BURKICK ELI 280 ELECTROCARDIOGRAPH (EKG)

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MORTARA INSTRUMENT, INC. BURKICK ELI 280 ELECTROCARDIOGRAPH (EKG) Back to Search Results
Model Number ELI280
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Burn(s) (1757); Tingling (2171); Electric Shock (2554)
Event Date 09/14/2017
Event Type  Malfunction  
Event Description

Nurse was hooking up leads and wires of ekg to pt. As the nurse put a wire to a lead, the wire went across the pt's chest and the pt said she felt something burning her. Pt asked the nurse what it was and nurse told her she did not know because the (ekg) machine was not on. Pt stated it was like an electrical shock. Pt states she got home and had some tingling and found a pad left on her chest, that is when she found what looks like a burn on her chest.

 
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Brand NameBURKICK ELI 280
Type of DeviceELECTROCARDIOGRAPH (EKG)
Manufacturer (Section D)
MORTARA INSTRUMENT, INC.
milwaukee WI
MDR Report Key6979148
MDR Text Key90411118
Report NumberMW5072947
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberELI280
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

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