cardiofax M ECG-1350ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04931921110713), received between Dec 4, 2017 and Feb 9, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

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.

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.

• MalfunctionFeb 9, 2024Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ELECTROCARDIOGRAPH (ECG) WAS GIVING INACCURATE READINGS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676332 ↗
• MalfunctionMar 1, 2023Output Problem; Output Problem

  THE OFFICE ASSISTANT REPORTED THAT THE UNIT DOES NOT SEEM TO FUNCTION CORRECTLY. THE UNIT IS NOT READING CORRECTLY, AND THE RESPONSE TO THE PATIENT'S VITALS ARE NOT COMING OUT WELL. THIS IS ALL THE INFORMATION THAT THEY HAD. THERE WERE NO ERROR MESSAGES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464985 ↗
• MalfunctionSep 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE NURSE REPORTS THAT THEIR ECG UNIT WAS DISPLAYING WAVEFORMS THAT THE PHYSICIANS DID NOT AGREE WITH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8967769 ↗
• MalfunctionJul 3, 2019Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE ELECTROCARDIOGRAPH DEVICE DISPLAYED INACCURATE READINGS. NO CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8761393 ↗
• MalfunctionDec 4, 2017Output Problem; Output Problem

  THE NURSE REPORTS THAT THE PULSE IS READING LOW ON THE ECG-1350A. THEY MEASURED THE PATIENT'S PULSE MANUALLY AND VERIFIED THE ECG IS NOT REPORTING THE PULSE CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Patient Problem/Medical Problem

  MAUDE report 7081548 ↗