HOMECG+

Additional Manufacturer Narrative

THE BATTERIES IN THE DEVICE WERE REPLACED AND TESTED. THE DEVICE WAS UPDATED TO THE LATEST FIRMWARE AND WAS FOUND TO BE FULLY FUNCTIONAL. 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 POWERS DOWN PRIOR TO OBTAINING A SUCCESSFUL SCAN. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.