MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 ERGO WAM WLAN USB DICOM SEC AHA B; ELECTROCARDIOGRAPH

Model Number ELI380-DCS11

Device Problem Wireless Communication Problem (3283)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

The customer reported that the eli380 was intermittently dropping wifi connection and not transmitting data.This complaint was captured under hillrom ref (b)(4).

Manufacturer Narrative

The eli 380 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.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 unit was returned for bench repair where the hrc technician found that the device would connect to the network but would not transmit a record and it was determined that the issue was with the radio card, the hrc technician replaced the radio card and updated the software to resolve the issue.Based on this information, no further actions are required at this time.Although there was no injury reported, if the eli380 were to intermittently drop wifi connection, it could lead to a serious injury or death.Therefore, hillrom is reporting this event.

• 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 Key: 18806430
• MDR Text Key: 336857129
• Report Number: 2183461-2024-00004
• Device Sequence Number: 1
• Product Code: DPS
• 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: 02/29/2024

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/29/2024
• 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 Number: 1