CURRENT HEALTH LTD SECOND GENERATION

Description of Event or Problem

UPON HOME HEALTH NURSE VISIT ON (B)(6) 2020 PATIENT REPORTED SHE WAS BURNED BY THE UNIT SENSOR ON HER UPPER OUTER LEFT ARM. SECOND DEGREE BURN NOTED, NO MEDICAL TREATMENT REQUIRED BY MD OR EMERGENCY DEPARTMENT. NOTIFIED CURRENT HEALTH CONTACT AND WAS INSTRUCTED TO SHIP THE UNIT BACK TO THE COMPANY FOR TESTING AND EVALUATION. SHIPPED BACK TO COMPANY ON (B)(6) 2020 ACCORDING TO MANUFACTURE REQUIREMENTS. REPORTED UP TO HOME CARE/HOSPITAL RISK MANAGEMENT, SENIOR LEADERSHIP, PATIENT PHYSICIAN, AND ALL APPROPRIATE REPORTS COMPLETED. ALL ADDITIONAL GENERATION 2 CURRENT HEALTH TELEHEALTH SYSTEMS REMOVED FROM HOME CARE PATIENTS UNTIL EVALUATION AND TESTING IS COMPLETED BY MANUFACTURER. MANUFACTURER IN FULL SUPPORT OF REMOVING ALL UNITS UNTIL TESTING COMPLETED.