MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 LCD WAM WLAN USB DICOM AHA BAN; ELECTROCARDIOGRAPH

Model Number ELI380-ACX11

Device Problem Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

The eli 380 (12-lead and 15-lead) is intended to be a high-performance, multichannel resting electrocardiograph.As a resting electrocardiograph, the eli 380 simultaneously acquires data from each lead.Once the data is acquired, it can be analyzed, reviewed, stored, printed, or transmitted.It is a device primarily intended for use in hospitals but may be used in medical clinics and offices of any size.The device ifu states this is an electrocardiograph that is intended to be used with the welch allyn wireless acquisition module (wam).Per the ifu ecg troubleshooting chart the following is noted: (affected leads) with wam connected: real-time screen or ecg printouts have missing data (i.E., blank gap in waveform) and/or, ecg can only be acquired by selecting ecg button twice (forced acquire) and/or, interpretation statements/measurements are not printed on report.(problem) unstable wam connection preventing eli 380 from recording data.(correction) reposition wam for better wireless connection (see notes under user safety information).If unable to secure better connection, use am12 for wired connection instead.If problem persists, call welch allyn customer service to search for possible radio interference sources.Follow-up attempts were made with the customer, however, they have not provided any further details of the initial alleged delay in treatment associated with the device, including: number of patients with involved delays, date of delays, specifics in the delay of treatment, sequence of events, did the device provide an alert/alarm, length of delay allegations, device serial numbers associated with each patient, and additional patient information including admitting diagnoses, past medical history, gender, age and weight, and each patient¿s outcome.Hillrom has received no information back on the above, but the customer did confirm no patient injury from the event.Inspection by a hillrom technician noted the device to be functioning as designed.It was additionally found the customer was using 3rd party manufacturer lead clips for each machine and it was suggested that new lead clips be ordered.There was no malfunction identified, and at this time, no report of life-threatening injury, permanent impairment of a body function, or medical or surgical intervention provided to preclude permanent impairment of a body function, indicating no serious injury occurred.However, if there was a recurrence of the device malfunction losing connection to the wireless network resulting in the inability to transmit or receive ekgs (leading to delayed treatment) it is likely to cause or contribute to a serious injury or death if the stat feature of the ecg is not utilized.Therefore, hillrom is reporting this alleged connection failure as a product malfunction.

Event Description

It was reported that patients in the emergency department were receiving delayed treatment due to malfunction of an eli 380 device not downloading patient data to the customer cerner, electronic health record platform, and not providing ekg tracing on the screen.There was no patient/user injury reported.This event has been captured under hillrom ref #(b)(4).

• Brand Name: ELI380 LCD WAM WLAN USB DICOM AHA BAN
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15857524
• MDR Text Key: 307705775
• Report Number: 2183461-2022-00041
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00812345024531
• UDI-Public: 812345024531
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2022

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1