MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380; ELECTROCARDIOGRAPH

Model Number	ELI380-ACX11
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
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.Troubleshooting determined that the device was running on an older software version.The customer was advised to perform a hard reset of the device to reconnect to the network and the customer will upload the latest firmware version to resolve the ongoing connectivity issue.Based on this information, no further action is required at this time if the eli 380 device loses connection to the wireless network, the device is unable to transmit or receive ekg¿s.Based on an analysis of the risk file, a failed connection on an eli380 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.
Event or Problem Description
The customer reported intermittent connection issues with the eli380 unit.This incident was captured under hillrom complaint ref # (b)(4).
Event or Problem Description
The customer reported intermittent connection issues with the eli380 unit.This incident was captured under baxter 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.

• Brand Name: ELI380
• 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: 17852328
• Report Number: 2183461-2023-00023
• Device Sequence Number: 11610491
• Product Code: DPS
• UDI-Device Identifier: 00812345024531
• UDI-Public: (01)00812345024531
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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-ACX11
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/02/2023
• 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