inforMED
MalfunctionMWJ

DIGITRAK XT HOLTER

Received Oct 20, 2025 · Event occurred Aug 26, 2025

Report 23335138 · MDR key 23335138

Device

Generic name

Electrocardiograph,ambulatory(without Analysis)

Product problems

  • Display or Visual Feedback Problem
  • Mechanical Problem

Patient

77 YR · Female

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

Narrative

Description of Event or Problem

COWORKER REACHED OUT TO ME. PATIENT RETURN HOLTER TO THE [REDACTED] OFFICE. WHEN THEY WENT TO DOWNLOAD IT, THE HOLTER DISPLAYED AN ERROR MESSAGE. WE WERE UNABLE TO DOWNLOAD THE HOLTER AND SEE THE REORDERED INFORMATION. BILLERS WERE ASKED TO CREDIT THE HOOK-UP, ORDERING MD WAS ASKED IF THEY WANT THE HOLTER REPEATED. HOLTER WAS PULLED FROM SERVICE AND SENT FOR REPAIR.