MalfunctionDXH
HOMECG+
Received Aug 22, 2025
Report 3012267350-2025-00012 · MDR key 22874400
Device
Generic name
Transmitters And Receivers, Electrocardiograph, Telephone
Manufacturer
Lohman Technologies, LlcModel number
V2.0Lot number
2021 - 168283
Product problems
- Power Problem
- Power Problem
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 TURNS ON AND READS "FACTORY RESET" THEN SHUTS BACK OFF AFTER CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Additional Manufacturer Narrative
THE POWER BUTTON APPEARED TO BE STUCK, WHICH RESULTED IN THE "FACTORY RESET" AND DEAD BATTERIES, WHICH CAUSED THE DEVICE TO CONSTANTLY TURN ON, RESET, AND TURN OFF.
Remedial action
- Replace