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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC. ELI 380 ELECTROCARDIOGRAPH

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MORTARA INSTRUMENT, INC. ELI 380 ELECTROCARDIOGRAPH Back to Search Results
Model Number ELI380
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2018
Event Type  Malfunction  
Event Description

While attempting to perform an ecg the nurse activated the wireless access module (wam), the device would not connect with the mortara eli380 ecg machine. Another machine was used with the same result (different wam module also. Staff changed batteries, attempted to use the other wam modules to see if they had gotten mixed up - it did not work. Staff called for another machine and the ecg was performed after a short delay, no patient harm. Manufacturer response for ecg machine, mortara (per site reporter) discussed with service technician issue was likely related to electrical interference of some type, which probably resolved by the time the other machine, arrived. Could not duplicate the issue. We have ordered a back-up hard wired trunk cable to use in case of future issues with the wireless module to minimize delay time to diagnostic ecg.

 
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Brand NameELI 380
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
MORTARA INSTRUMENT, INC.
7865 n 86th. st
milwaukee WI 53224
MDR Report Key7302142
MDR Text Key101175977
Report Number7302142
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 RISK MANAGER
Type of Report Initial
Report Date 02/23/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/28/2018
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberELI380
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/23/2018
Device Age1 yr
Event Location Hospital
Date Report TO Manufacturer02/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/28/2018 Patient Sequence Number: 1
Treatment
NO
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