MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 ERGO WAM WLAN USB DICOM IEC BAN; ELECTROCARDIOGRAPH

Model Number ELI380-DCX12

Device Problem Wireless Communication Problem (3283)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

The biomed reported that after the device was repaired, it had unstable wifi connection.There was no patient involvement reported.This incident was captured under hillrom complaint ref (b)(4).

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.Technical services advised the biomed to perform a hard reset and wipe all wlan settings and then re configure the unit to resolve the issue.The customer was advised to contact baxter if the problem persisted.Although there was no patient injury reported, if the eli 380 device loses connection to the wireless network, the device is unable to transmit or receive ekg¿s, which may result in a delay of patient treatment which could cause or contribute to a serious injury or death.Therefore, hillrom is reporting this reported connection failure as a product malfunction.

• Brand Name: ELI380 ERGO WAM WLAN USB DICOM IEC BAN
• 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: 18912158
• MDR Text Key: 337756380
• Report Number: 2183461-2024-00006
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00732094265200
• UDI-Public: 732094265200
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

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-DCX12
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/15/2024
• 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