ELI 380 ELI380-ACX21Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812345024562), received between Jul 11, 2023 and Jul 8, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Intermittent Communication Failure; Intermittent Communication Failure

  BAXTER RECEIVED A COMPLAINT FROM THE CUSTOMER REPORTING ISSUES SUBMITTING ORDERS. THE WLAN, CUSTOM ID, AND OTHER OPTIONS GREY OUT INTERMITTENTLY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688450 ↗
• MalfunctionJul 14, 2023Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE ELI380 INTERMITTENTLY LOSES WLAN CONNECTIVITY. THE NETWORK CARD IS NOT RECOGNIZED. AFTER A WHILE IT TURNS ON BUT THEN SAYS IT CAN¿T READ THE WORKLIST. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324953 ↗
• MalfunctionJul 11, 2023Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE ELI 380 WAS HAVING INTERMITTENT CONNECTION ISSUES. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297136 ↗

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