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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 ERGO WAM WLAN USB DICOM SEC AHA B ELECTROCARDIOGRAPH

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MORTARA INSTRUMENT ELI380 ERGO WAM WLAN USB DICOM SEC AHA B ELECTROCARDIOGRAPH Back to Search Results
Model Number ELI380-DCS11
Device Problem Wireless Communication Problem (3283)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
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Brand NameELI380 ERGO WAM WLAN USB DICOM SEC AHA B
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
MORTARA INSTRUMENT
7865 n 86th street
milwaukee WI 53224
Manufacturer Contact
emily mitchell
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key10678608
Report Number2183461-2020-00023
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 Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 09/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberELI380-DCS11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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