ELI 380 ELI380-ACX11Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00812345024531), received between Dec 10, 2020 and Apr 15, 2024 — classified as 8 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. 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE ELI 380 WAS HAVING ROAMING ISSUES WITH WIFI. 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 19108687 ↗
• MalfunctionJan 8, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED INTERMITTENT WIFI ISSUES WITH THE ELI380 UNIT. THERE WAS NO INJURY REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18463439 ↗
• MalfunctionOct 2, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED INTERMITTENT CONNECTION ISSUES WITH THE ELI380 UNIT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852328 ↗
• MalfunctionNov 28, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT PATIENTS IN THE EMERGENCY DEPARTMENT WERE RECEIVING DELAYED TREATMENT DUE TO MALFUNCTION OF AN ELI 380 DEVICE NOT DOWNLOADING PATIENT DATA TO THE CUSTOMER CERNER, ELECTRONIC HEALTH RECORD PLATFORM, AND NOT PROVIDING EKG TRACING ON THE SCREEN. THERE 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 15868083 ↗
• MalfunctionNov 23, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT PATIENTS IN THE EMERGENCY DEPARTMENT WERE RECEIVING DELAYED TREATMENT DUE TO MALFUNCTION OF AN ELI 380 DEVICE NOT DOWNLOADING PATIENT DATA TO THE CUSTOMER CERNER, ELECTRONIC HEALTH RECORD PLATFORM, AND NOT PROVIDING EKG TRACING ON THE SCREEN. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS EVENT HAS BEEN CAPTURED UNDER HILLROM REF #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15857524 ↗
• MalfunctionJul 12, 2022Intermittent Communication Failure; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THEY WERE HAVING TROUBLE STAYING CONNECTED TO THE NETWORK USING THE ELI380. THERE WAS NO PATIENT / USER INJURY REPORTED. THIS COMPLAINT WAS FILED UNDER HILL-ROM REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986628 ↗
• MalfunctionJan 6, 2022Smoking; Sparking; Smoking; Sparking

  AS A RESULT OFF THE MONTHLY MAUDE SEARCH, HILLROM BECAME AWARE OF A MEDWATCH REPORT OF A FLASH OF LIGHT AND SMOKE EVENT REGARDING AN ELI380 ELECTROCARDIOGRAPH. INFORMATION ON THE COMPLAINANT AND THE DEVICE, INCLUDING CONTACT DETAILS, LOCATION AND SERIAL NUMBER, WERE NOT PROVIDED IN THE REPORT RECEIVED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13176057 ↗
• MalfunctionDec 10, 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 10983285 ↗

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