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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC. ELI 280 ELECTROCARDIOGRAPH

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MORTARA INSTRUMENT, INC. ELI 280 ELECTROCARDIOGRAPH Back to Search Results
Catalog Number ELI280-CAA-AAFAD
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 07/10/2017
Event Type  Malfunction  
Event Description

The bracket that holds the wireless acquisition module(wam) has broken. We continue to see this quite a bit; it should be reinforced. Manufacturer response for ekg cart, eli280 (per site reporter). We just order a new part and repair it. But even while under warranty this bracket was not covered.

 
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Brand NameELI 280
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
MORTARA INSTRUMENT, INC.
7865 north 86th st.
milwaukee WI 53224
MDR Report Key6777174
MDR Text Key82174020
Report Number6777174
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 BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 07/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberELI280-CAA-AAFAD
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/10/2017
Device Age2 yr
Event Location Hospital
Date Report TO Manufacturer07/10/2017
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: 08/09/2017 Patient Sequence Number: 1
Treatment
NO; NO OTHER THERAPIES
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