MalfunctionDXH
HOMECG+
Received Aug 22, 2025
Report 3012267350-2025-00002 · MDR key 22874184
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
NEW BATTERIES WERE ADDED TO THE DEVICE AND THE DEVICE WAS FUNCTIONAL. THE DEVICE WAS ALSO UPDATED TO THE LATEST FIRMWARE AND WAS ABLE TO SUCCESSFULLY FUNCTION AND UPLOAD DATA, AS INTENDED.
Description of Event or Problem
THE PATIENT REPORTS COLLECTING STEADY READINGS SINCE RECEIVING THE DEVICE BUT HAS STARTED EXPERIENCING ISSUES WITH GETTING A READING. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Remedial action
- Replace