inforMED
MalfunctionDXH

HOMECG

Received Dec 12, 2025

Report 3012267350-2025-00016 · MDR key 23791391

Device

Generic name

Transmitters And Receivers, Electrocardiograph, Telephone

Model number

V2.0

Product problems

  • Power Problem
  • Power Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE PATIENT REPORTS THAT THE DEVICE TURNS ON AND TURNS OFF AFTER A FEW SECONDS DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED THEREFORE THE PROBLEM STATEMENT/COMPLAINT COULD NOT BE CONFIRMED.

Remedial action

  • Replace