Midmark Midmark Digital ECGRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08056732652491), received between May 2, 2024 and May 2, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Readings” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. Jul 20, 2026Open, Classified

   A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

   Z-3013-2026 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2024Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  IT WAS REPORTED THAT HIGH HEART RATES FROM 7 ECG DEVICES WERE SHOWN ON THE ECG REPORTS. THE FOLLOWING SERIAL NUMBERS ARE: (B)(6) THE CUSTOMER STATED THAT THE DOUBLING OF HEART RATES WERE SEEN ON A SINGLE PATIENTS ECG REPORT. A PATIENT WAS PRESCRIBED HEART MEDICATION (CARDIZEM) AS THEIR REPORT SHOWED HIGH HEART RATE. THE MEDICATION WAS NOT CONSUMED BY THE PATIENT AND TACHYCARDIA WAS RULED OUT BY A LIVE HOLTER MONITORING DEVICE. TECHNICAL SERVICE REACHED OUT TO THE CUSTOMER TO TROUBLESHOOT AND WAS UNABLE TO RECREATE THE ISSUE WITH THE ECG UNITS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234611 ↗