MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 ERGO AM12 WLAN USB DICOM AHA BAN; ELECTROCARDIOGRAPH

Model Number	ELI380-DCX21
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.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.The customer will have the software of the eli380 device upgraded to a new software version to correct the reported issue.Based on this information, no further action is required at this time.
Event or Problem Description
Hillrom received a report from the account stating that the eli 380 device was having difficulty remaining connected to the wireless network.The device was located in the account at the time of the event.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint#: (b)(4).

• Brand Name: ELI380 ERGO AM12 WLAN USB DICOM AHA BAN
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• MDR Report Key: 10602847
• Report Number: 2183461-2020-00018
• Device Sequence Number: 3232376
• Product Code: DPS
• UDI-Device Identifier: 00812345026986
• UDI-Public: 812345026986
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

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
• Operator of Device: No Information
• Device Model Number: ELI380-DCX21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1