MalfunctionDXH
HOMECG+
Received Aug 22, 2025
Report 3012267350-2025-00004 · MDR key 22874252
Device
Generic name
Transmitters And Receivers, Electrocardiograph, Telephone
Manufacturer
Lohman Technologies, LlcModel number
V2.0Lot number
2021 - 168282
Product problems
- Failure to Power Up
- Failure to Power Up
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE PATIENT REPORTS THAT THE DEVICE DOES NOT TURN ON, EVEN DESPITE A BATTERY CHANGE. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Additional Manufacturer Narrative
THE BATTERIES IN THE DEVICE APPEARED TO BE LOW IN VOLTAGE. HOWEVER, THERE WAS AN ISSUE WITH THE FIRMWARE THAT PREVENTED THE DEVICE FROM TURNING ON WHEN THE BATTERIES WERE LOW EVEN THOUGH THE REQUIRED VOLTAGE TO TURN THE DEVICE ON WAS MET.
Remedial action
- Replace