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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 Date 12/07/2020
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.No further information is available on the repair of the device at this time.The investigation is ongoing and the investigation and resolution details will be submitted in a supplemental report.
 
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).
 
Manufacturer Narrative
The customer was contacted for follow up.The customer reported the issue was resolved and the customer had decided to connect to the network via lan.Based on this information, no further action is required.
 
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 Name
ELI380 ERGO WAM WLAN USB DICOM SEC AHA B
Type of Device
ELECTROCARDIOGRAPH
Manufacturer (Section D)
MORTARA INSTRUMENT
7865 n 86th street
milwaukee WI 53224
MDR Report Key11116946
MDR Text Key234330981
Report Number2183461-2021-00001
Device Sequence Number1
Product Code DPS
UDI-Device Identifier00812345026917
UDI-Public812345026917
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
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
Was the Report Sent to FDA? No
Date Manufacturer Received12/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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