Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORTARA INSTRUMENT LNR, ELI 380 TOUCHSCREEN DISPLAY; ELECTROCARDIOGRAPH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MORTARA INSTRUMENT LNR, ELI 380 TOUCHSCREEN DISPLAY; ELECTROCARDIOGRAPH Back to Search Results
Model Number ELI380D-L
Device Problem Wireless Communication Problem (3283)
Patient Problem No Patient Involvement (2645)
Event Date 11/12/2020
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 investigation of the device at this time.The investigation is ongoing, however, if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
 
Event Description
Hillrom received a report from the account stating that the eli 380 device would not connect 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 product support specialist contacted the customer regarding the alleged connectivity issue with the eli 380 device.The customer reported that the configuration and connectivity issue was user error and they were able to correct the issue.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 not connect 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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LNR, ELI 380 TOUCHSCREEN DISPLAY
Type of Device
ELECTROCARDIOGRAPH
Manufacturer (Section D)
MORTARA INSTRUMENT
7865 n 86th street
milwaukee WI 53224
MDR Report Key10985340
MDR Text Key223817196
Report Number2183461-2020-00038
Device Sequence Number1
Product Code DPS
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 01/13/2021
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 NumberELI380D-L
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-