inforMED
MalfunctionDXH

HOMECG+

Received Sep 12, 2025

Report 3012267350-2025-00014 · MDR key 23043095

Device

Generic name

Transmitters And Receivers, Electrocardigraph, Telephone

Model number

V2.0

Lot number

2021 - 16828

Product problems

  • Power Problem
  • Power Problem

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

THE BATTERIES ON THE DEVICE WERE REPLACED AND TESTED. THE DEVICE TOOK A SCAN AND UPDATED THE TIME BUT THE SCAN WAS NOT UPLOADED TO THE CLOUD. THE DEVICE IS IN PROGRESS OF BEING UPDATED. UPON TESTING OF OTHER DEVICES WITH THE SAME ISSUE, A MALFUNCTION WAS IDENTIFIED THAT PREVENTED THE DEVICE FROM TURNING ON WHEN THE BATTERIES WERE LOW EVEN THOUGH THE REQUIRED VOLTAGE TO TURN THE DEVICE ON WAS MET.

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 FROM THIS PROBLEM.

Remedial action

  • Replace