ELI 380 ELI380-ACS11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812345026313), received between Apr 7, 2022 and Nov 9, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Intermittent Communication Failure” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2022Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE DEVICE IS INTERMITTENTLY LOSING WI-FI CONNECTION. 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 15758557 ↗
• MalfunctionApr 7, 2022Intermittent Communication Failure; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THE ELI380 UNIT WOULD LOSE WIRELESS ACCESS AND HAD TO BE RESET BETWEEN PATIENTS. THERE WAS NO PATIENT INJURY REPORTED. THIS COMPLAINT HAS BEEN CAPTURED UNDER HILLROM REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043238 ↗

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