inforMED
MalfunctionMWJ

DIGITRAK XT

Received Jul 22, 2025 · Event occurred Jul 7, 2025

Report 22564237 · MDR key 22564237

Device

Generic name

Electrocardiograph,ambulatory(without Analysis)

Catalog number

860322

Product problems

  • Defective Device
  • Device Displays Incorrect Message
  • Output Problem

Patient

24 YR · Male

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

PATIENT'S MOTHER CALLED A LEFT A MESSAGE ON THE CARD TECH PHONE LINE. A FEW HOURS AFTER WEARING THE HOLTER MONITOR, THE HOLTER DISPLAYED A ERROR MESSAGE OF DEFECTIVE CARD. HOLTER WAS WORKING WHEN APPLIED. I E- MESSAGED ORDERING MD TO SEE IF THEY WANT THE HOLTER REPEATED. MESSAGED THE BILLERS TO NOT BILL FOR THE HOOK-UP CHARGE. HOLTER WILL BE SENT IN FOR REPAIR.