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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 LCD WAM WLAN USB DICOM AHA BAN; ELECTROCARDIOGRAPH
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MORTARA INSTRUMENT ELI380 LCD WAM WLAN USB DICOM AHA BAN; ELECTROCARDIOGRAPH Back to Search Results
Model Number ELI380-ACX11
Device Problem Wireless Communication Problem (3283)
Patient Problem No Patient Involvement (2645)
Event Date 11/13/2020
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 (b)(4) 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).
 
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 device was returned for evaluation.The eli380 device was upgraded to a new software version to correct the reported issue.Following this, the device was working as designed.Based on this information, no further action is required at this time.
 
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Brand Name
ELI380 LCD WAM WLAN USB DICOM AHA BAN
Type of Device
ELECTROCARDIOGRAPH
Manufacturer (Section D)
MORTARA INSTRUMENT
7865 n 86th street
milwaukee WI 53224
MDR Report Key10983285
MDR Text Key250090729
Report Number2183461-2020-00036
Device Sequence Number1
Product Code DPS
UDI-Device Identifier00812345024531
UDI-Public812345024531
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberELI380-ACX11
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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