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ELI 380 ELI380-DCS43Recalls & reported problems

Mortara Instrument, Inc. · Electrocardiograph · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812345026948), received between Apr 23, 2021 and Apr 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Wireless Communication Problem” (1 report).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K142105); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Nov 11, 2020Terminated

    The radio within the device can become disassociated with the wireless access point.

    Z-0553-2021 · Root cause: Software design · FDA record ↗

Most reported problems

Device problems

  • Wireless Communication Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 23, 2021Wireless Communication Problem; Wireless Communication Problem

    HILLROM RECEIVED A REPORT FROM THE ACCOUNT STATING THAT THE ELI 380 DEVICE WOULD NOT CONNECT TO THE WIRELESS NETWORK. THE DEVICE WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11716669 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142105. One submission often covers many models, so check the product and lot details in each record.

  • Z-1013-2023 · Oct 31, 2022 · Terminated
    Baxter Electrocardiograph, ELI 380 -DCS21
  • Z-1483-2021 · Mar 31, 2021 · Terminated
    ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediat
  • Z-1796-2015 · May 29, 2015 · Terminated
    ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously a

Other Electrocardiograph devices

All Electrocardiograph devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.