inforMED
MalfunctionDXH

HOMECG+

Received Dec 12, 2025

Report 3012267350-2025-00018 · MDR key 23791389

Device

Generic name

Transmitters And Receivers, Electrocardiograph, Telephone

Model number

V2.0

Product problems

  • Communication or Transmission Problem
  • Communication or Transmission 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 BLINKS A BLANK SCREEN DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.

Additional Manufacturer Narrative

THE DEVICE IS UNABLE TO COMPLETE THE BOOT-UP PROCESS DUE TO A FAILURE OF THE INTERNAL FLASH ON THE MAIN PROCESSOR.

Remedial action

  • Replace