ELI 380 ELI380-DCS21Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00812345026924), received between Jan 20, 2021 and Nov 18, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE ELI380 WAS NOT TRANSMITTING PROPERLY. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER COMPLAINT REF #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704810 ↗
• MalfunctionSep 26, 2024

  THE EKG UNIT SCREEN IS SUPPORTED BY A HINGE THAT SUPPORTS THE DISPLAY TO OPEN AND CLOSE. THIS HINGE IS GETTING CRACKED ON VARIOUS POINTS AND IS PREVENTING THE DISPLAY TO LIGHT UP TO SHOW THE PATIENT EKG. THIS HAS BEEN EXPERIENCED ON A COUPLE OF OUR UNITS SO FAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310396 ↗
• MalfunctionJul 14, 2023Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THEIR ELI 380 WAS INTERMITTENTLY NOT CONNECTING TO THE NETWORK, IT WAS ADDITIONALLY REPORTED THE UNIT HAD DISPLAY ISSUES. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325148 ↗
• MalfunctionApr 7, 2022Intermittent Communication Failure; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THE DEVICE IS INTERMITTENTLY DROPPING WLAN CONNECTION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # C-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14039878 ↗
• MalfunctionJan 20, 2021Wireless 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 IN THE EMERGENCY DEPARTMENT 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 11201357 ↗

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