MalfunctionDXH
HOMECG+
Received Sep 12, 2025
Report 3012267350-2025-00013 · MDR key 23043096
Device
Generic name
Transmitters And Receivers, Electrocardiograph, Telephone
Manufacturer
Lohman Technologies, LlcModel number
V2.0Lot number
2021 - 16828
Product problems
- Application Program Problem
- Application Program Problem
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER REPORTS CHALLENGES WITH LOST CONTACT WHEN PLACING THUMBS ON THE ELECTRODES. THE USER HAD NO ADVERSE EVENT OR REACTION FROM THIS PROBLEM.
Additional Manufacturer Narrative
THE DEVICE APPEARED TO BE OPERATING ON AN OLDER FIRMWARE VERSION WHICH WAS CAUSING ISSUES WHEN ATTEMPTING TO TAKE SCANS. AFTER DELIVERY OF THE DEVICE WITH UPDATED FIRMWARE, THE USER WAS ABLE TO SUCCESSFULLY OBTAIN SCANS. ADDITIONALLY, THE USER RECEIVED WRIST ELECTRODES.
Remedial action
- Repair