MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI 380; ELECTROCARDIOGRAPH

Model Number	ELI380-DCS11
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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).
Additional 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 or Problem 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).

• Brand Name: ELI 380
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18236782
• Report Number: 2183461-2023-00026
• Device Sequence Number: 7160058
• Product Code: DPS
• UDI-Device Identifier: 00812345026917
• UDI-Public: (01)00812345026917
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K142105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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 Number: ELI380-DCS11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown