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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 ERGO AM12 WLAN USB DICOM AHA BAN ELECTROCARDIOGRAPH

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MORTARA INSTRUMENT ELI380 ERGO AM12 WLAN USB DICOM AHA BAN ELECTROCARDIOGRAPH Back to Search Results
Model Number ELI380-DCX21
Device Problem Wireless Communication Problem (3283)
Patient Problem No Patient Involvement (2645)
Event Date 09/17/2020
Event Type  Malfunction  
Manufacturer Narrative

The eli 380 device is indicated for use to acquire, analyze, display, and print electrocardiograms. Device is indicated for use to provide interpretation of the data for consideration by a physician. Device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The interpretations of ecg offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. Device is indicated for use on adult and pediatric populations. The device is not intended to be used as a vital signs physiological monitor. If the eli 380 device loses connection to the wireless network, the device is unable to transmit or receive ekg¿s. This failed connection may result in a delay of patient treatment which may cause or contribute to a serious injury or death. Therefore, hillrom is reporting this alleged connection failure as a product malfunction. The customer was provided with the upgraded software version and installation instructions of the eli380 device to correct the reported issue. Based on this information, no further action is required at this time.

 
Event Description

Hillrom received a report from the account stating that the eli 380 device would drop connection to the wireless network. The device was located at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as complaint # (b)(4).

 
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Brand NameELI380 ERGO AM12 WLAN USB DICOM AHA BAN
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 Key10679121
MDR Text Key211340697
Report Number2183461-2020-00026
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 10/14/2020
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-DCX21
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 Received09/17/2020
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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