ELI 380 ELI380-DCX11Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00812345026979), received between Dec 3, 2020 and May 18, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Patient Data Problem

  THE CUSTOMER CONTACTED BAXTER TO REPORT THAT PATIENT DEMOGRAPHICS WERE SWITCHING WHEN SAVING. 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 25211570 ↗
• MalfunctionOct 16, 2025Overheating of Device; Overheating of Device

  CUSTOMER REPORTED THAT THE POWER BUTTON WAS GETTING HOT AND APPEARED TO BE BURNING A HOLE THROUGH THE MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308212 ↗
• MalfunctionNov 27, 2024Computer Software Problem; Computer Software Problem

  CUSTOMER REPORTED PATIENT RECORD MISMATCH. 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 20796362 ↗
• MalfunctionFeb 8, 2023Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THE ELI380 DEVICE WOULD NOT STAY CONNECTED TO THE WIRELESS NETWORK. THERE WAS NO PATIENT INJURY REPORTED. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16321682 ↗
• MalfunctionJan 11, 2023Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE ELI 380 INTERMITTENTLY CONNECTS AND DISCONNECTS FROM THE NETWORK, AND THE SYNC BUTTON NEEDED TO BE PRESSED MULTIPLE TIMES JUST TO GET THE UNIT TO SYNC. THE CUSTOMER REPORTED THIS WAS AN ISSUE WITH CONNECTION BECAUSE THE UNIT KEPT LOSING ITS IP ADDRESS EVEN THOUGH IT WAS NEAR A GOOD ACCESS POINT. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16136450 ↗
• MalfunctionNov 28, 2022Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE DEVICE IS INTERMITTENTLY LOSING CONNECTION TO THE WLAN. 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 15868040 ↗
• MalfunctionApr 15, 2022Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE ELI380 HAD NETWORK ISSUES. THERE WAS NO INJURY REPORTED. THIS EVENT HAS BEEN CAPTURED CAPTURED UNDER HILLROM REF # C-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118401 ↗
• MalfunctionApr 7, 2022Intermittent Communication Failure; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THE ELI380 UNIT WOULD NOT CONNECT TO THE WLAN. THERE WAS NO INJURY REPORTED. THIS EVENT HAS BEEN CAPTURED CAPTURED UNDER HILLROM REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043134 ↗
• MalfunctionMar 24, 2022Intermittent Communication Failure; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THEIR ELI 380 UNIT WOULD CONNECT TO A WLAN NETWORK AND THEN DROP OFF AND THE WLAN SETTING WOULD GREY OUT. 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 13879578 ↗
• InjuryJan 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  HILLROM RECEIVED A REPORT FROM THE ACCOUNT STATING LEAD REVERSAL OF AN ELI 380 AND A PATIENT HAVING DELAYED CARE AND UNNECESSARY MEDICATION/TREATMENT BECAUSE OF THE ERROR. HILLROM HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER REGARDING THE INCIDENT AS PART OF THE INVESTIGATION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #:(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13314101 ↗
• MalfunctionJan 12, 2021Disconnection; Wireless Communication Problem; Disconnection; Wireless Communication Problem

  HILLROM RECEIVED A REPORT FROM THE ACCOUNT STATING THAT THE ELI 380 DEVICE WOULD LOSE CONNECTION TO THE 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; No Patient Involvement

  MAUDE report 11154994 ↗
• MalfunctionDec 3, 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 10941095 ↗

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