HOMECG+
Received Aug 22, 2025
Report 3012267350-2025-00001 · MDR key 22873951
Device
Generic name
Transmitters And Receivers, Electrocardiograph, Telephone
Manufacturer
Lohman Technologies, LlcModel number
V2.0Lot number
2021 - 168283
Product problems
- Application Program Problem
- Application Program Problem
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE APPEARED TO BE OPERATING ON AN OLDER FIRMWARE VERSION WHICH WAS CAUSING ISSUES WHEN ATTEMPTING TO TAKE SCANS. THE DEVICE WAS TESTED, THEN UPDATED TO LATEST FIRMWARE AND WAS FOUND TO BE FUNCTIONAL. AFTER DELIVERY OF A NEW DEVICE WITH UPDATED FIRMWARE, THE PATIENT WAS ABLE TO SUCCESSFULLY OBTAIN SCANS.
Description of Event or Problem
THE PATIENT REPORTS RECEIVING AN UNABLE TO ANALYZE RESULT THE MAJORITY OF THE TIME WHEN ATTEMPTING READINGS. WHEN REVIEWING DATA UPLOADED TO THE CLOUD, THERE ARE INCONSISTENCIES IN THE DATA AVAILABLE. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Remedial action
- Replace