ELI 380 ELI380-DCX21Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812345026986), received between Sep 29, 2020 and Apr 5, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (5 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 11, 2020Class IITerminated

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

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2024Wireless Communication Problem; Wireless Communication Problem

  CUSTOMER REPORTED DEVICE UNABLE TO BE PINGED TO THE NETWORK AND CONNECTION IS DROPPING. HERE WAS NO PATIENT/USER INJURY REPORTED. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048931 ↗
• MalfunctionApr 4, 2024Wireless Communication Problem; Wireless Communication Problem

  CUSTOMER REPORTED DEVICE UNABLE TO BE PINGED TO THE NETWORK AND CONNECTION IS DROPPING. HERE WAS NO PATIENT/USER INJURY REPORTED. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046852 ↗
• MalfunctionMay 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ELI380 FAILED TO CONNECT TO THE NETWORK. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14276846 ↗
• MalfunctionOct 14, 2020Wireless Communication Problem; Wireless Communication Problem

  HILLROM RECEIVED A REPORT FROM THE ACCOUNT STATING THAT THE ELI 380 DEVICE WOULD DROP CONNECTION 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 Patient Involvement

  MAUDE report 10679121 ↗
• MalfunctionOct 14, 2020Wireless Communication Problem; Wireless Communication Problem

  HILLROM RECEIVED A REPORT FROM THE ACCOUNT STATING THAT THE ELI 380 DEVICE WOULD DROP CONNECTION 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 Patient Involvement

  MAUDE report 10678988 ↗
• MalfunctionSep 29, 2020Wireless Communication Problem; Wireless Communication Problem

  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).

  Patient problems: No Patient Involvement

  MAUDE report 10602847 ↗

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