ELI 280 ELI280-CAA-AAFBDRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00812345026252), received between Jul 9, 2021 and Jul 5, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Patient Data Problem” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K122073); 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.

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.

• MalfunctionJul 5, 2023Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE ELI280 HAD INTERMITTENT CONNECTIVITY ISSUES. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17256481 ↗
• MalfunctionSep 12, 2022Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT THEY¿VE NOTICED SOME ECG TESTS WERE BEING ATTACHED TO THE WRONG PATIENTS¿ CHART. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT WAS CAPTURED UNDER HILL-ROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401311 ↗
• MalfunctionSep 9, 2022Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT THEY¿VE NOTICED SOME ECG TESTS WERE BEING ATTACHED TO THE WRONG PATIENTS¿ CHART. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT HAS BEEN CAPTURED UNDER HILLROM COMPLAINT REF#: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15390899 ↗
• MalfunctionOct 16, 2021Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED SHE WENT TO COMPLETE AN EKG. WHEN SHE TURNED THE CART ON, THERE WAS AN EKG TRACING ON THE CART. SHE TRANSMITTED THE EKG. AFTER SHE TRANSMITTED, SHE WENT TO ENTER THE DEMOGRAPHIC AND ANOTHER PATIENT'S INFORMATION WAS ALREADY IN THE DEMOGRAPHIC FIELDS. SHE MANUALLY DELETED ALL THE PREVIOUS PATIENT'S DEMOGRAPHICS BEFORE SHE COULD ENTER THE CURRENT PATIENT. THE EKG OF THE PATIENT WHOSE DEMOGRAPHICS WERE FOUND TO HAVE TRANSMITTED 2 TIMES AT APPROX 2.5 MINUTES APART, BOTH COMING FROM THE SAME CART. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643867 ↗
• MalfunctionJul 9, 2021Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED STUDIED THAT ARE PERIODICALLY SENT FROM THE ELI280 ECG DEVICE HAVE THE INCORRECT DEMOGRAPHIC INFORMATION. THE CUSTOMER NOTED THAT IT APPEARED THAT DEMOGRAPHIC INFORMATION IS BEING CHANGED ON AN EXISTING STUDY ON THE ELI280 AND IS SENT OUTBOUND WITH THE SAME STUDY ID, CHANGING THE INFORMATION IN THE CUSTOMER'S EPIPHANY SYSTEM. THE DEMOGRAPHIC INFORMATION IS BEING UPDATED TO INFORMATION OF A NEWLY PERFORMED ECG. THE DEVICE WAS LOCATED AT THE ACCOUNT AT THE TIME OF THE REPORTED EVENT. 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 12146717 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122073. One submission often covers many models, so check the product and lot details in each record.

• Z-0011-2022 · Sep 3, 2021 · Open, Classified
  ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-B
• Z-1482-2021 · Mar 31, 2021 · Terminated
  ELI 280 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