HOMECG+
Received Sep 12, 2025
Report 3012267350-2025-00014 · MDR key 23043095
Device
Generic name
Transmitters And Receivers, Electrocardigraph, Telephone
Manufacturer
Lohman Technologies, LlcModel number
V2.0Lot number
2021 - 16828
Product problems
- Power Problem
- Power Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BATTERIES ON THE DEVICE WERE REPLACED AND TESTED. THE DEVICE TOOK A SCAN AND UPDATED THE TIME BUT THE SCAN WAS NOT UPLOADED TO THE CLOUD. THE DEVICE IS IN PROGRESS OF BEING UPDATED. UPON TESTING OF OTHER DEVICES WITH THE SAME ISSUE, A MALFUNCTION WAS IDENTIFIED THAT PREVENTED THE DEVICE FROM TURNING ON WHEN THE BATTERIES WERE LOW EVEN THOUGH THE REQUIRED VOLTAGE TO TURN THE DEVICE ON WAS MET.
Description of Event or Problem
THE PATIENT REPORTS THAT THE DEVICE TURNS ON AND TURNS OFF AFTER A FEW SECONDS DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION FROM THIS PROBLEM.
Remedial action
- Replace