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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2023
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.The device was returned for repair where the reported issues were verified.The device failed the functional check.The problem was determined to be with the motherboard and keyboard.The hrc technician replaced the motherboard, keyboard/upper housing, utk and replaced the monitors to resolve the reported problems.The software was also updated to version 2.6.1.1.And the customer was advised to reset their wlan and lan settings.Based on this information, no further actions are required at this time.If the eli 380 device loses connection to the wireless network, the device is unable to transmit or receive ecg¿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 connection failure as a product malfunction.
 
Event Description
The customer reported a number of issues with the eli380 including the wired and wireless network connections would simply stop working but then come back with no action taken.The customer also stated that when any of those conditions occur, the screen goes blank.There was no associated adverse event reported with this complaint.This incident was captured under hill-rom complaint ref # (b)(4).
 
Manufacturer Narrative
This supplemental report is a correction to the previously submitted mdr.Following communication from the fda regarding incorrect/missing udi numbers, baxter reviewed the subject mdr and determined brand name, 510k, and udi corrections were required to this mdr in alignment with the gudid.
 
Event Description
The customer reported a number of issues with the eli380 including the wired and wireless network connections would simply stop working but then come back with no action taken.The customer also stated that when any of those conditions occur, the screen goes blank.There was no associated adverse event reported with this complaint.This incident was captured under baxter complaint ref (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
Manufacturer Contact
keighley crosthwaite
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key18236782
MDR Text Key329358640
Report Number2183461-2023-00026
Device Sequence Number1
Product Code DPS
UDI-Device Identifier00812345026917
UDI-Public812345026917
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberELI380-DCS11
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/02/2023
Initial Date FDA Received11/30/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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