HAMILTON T1

Additional Manufacturer Narrative

HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED TO HAMILTON MEDICAL AG THAT THE VENTILATOR DEVICE REPEATEDLY FAILED FOR THE LEAK TEST AND THE FLOW SENSOR CALIBRATION DURING THE PREOPERATIONAL CHECK. THE REPORTED ISSUE CAN BE VERIFIED FROM THE DEVICE LOGS. DUE TO THE DESCRIPTION, IMPACT ON THE PATIENT STATE OF HEALTH CANNOT BE EXCLUDED. IN THE PRESENT CASE, THERE WAS NO INDICATION FOR PATIENT HARM.

Additional Manufacturer Narrative

INVESTIGATION RESULT: DEVICE REPEATEDLY FAILED LEAK TEST AND FLOW SENSOR CALIBRATION IN PRE-OPP CHECK. NO PATIENT INVOLVEMENT. THE LEAK TEST THAT WAS NOT PASSED AND THE FAILED FLOW SENSOR CALIBRATION ARE PART OF MANDATORY TESTS PRIOR TO USING THE DEVICE ON A PATIENT. WHEN A HAMILTON VENTILATOR IS POWERED ON AT THE START OF THE DAY, USERS ARE REQUIRED TO PERFORM A SERIES OF PRE-USE TESTS BEFORE IT CAN BE USED ON A PATIENT. THESE TESTS ARE A STANDARD SAFETY PROTOCOL DESIGNED TO VERIFY THAT ALL CRITICAL COMPONENTS, INCLUDING ALARMS, SENSORS, CIRCUITS, AND VALVES, ARE FUNCTIONING CORRECTLY. THEIR PURPOSE IS TO ENSURE PATIENT SAFETY BY IDENTIFYING ANY POTENTIAL MALFUNCTIONS BEFORE VENTILATION BEGINS, MAKING THEM A MANDATORY STEP IN THE DEVICE¿S OPERATION. IF A VENTILATOR FAILS TO START UP, IT PREVENTS THE EXECUTION OF THESE MANDATORY SELF-TESTS AND, AS A RESULT, WILL NOT BE CLEARED FOR PATIENT USE. THIS MEANS THAT A STARTUP FAILURE DOES NOT POSE AN IMMEDIATE RISK TO A PATIENT, AS THE DEVICE WOULD NEVER BE PUT INTO OPERATION WITHOUT PASSING THE REQUIRED CHECKS. THE FAILURE IS CONTAINED WITHIN THE PRE-USE VERIFICATION PROCESS, ENSURING THAT NO FAULTY DEVICE IS USED FOR PATIENT CARE. CONSEQUENTLY, A FAILED STARTUP IS NOT CLASSIFIED AS A CRITICAL FAILURE OR A REPORTABLE EVENT UNDER STANDARD MEDICAL DEVICE REGULATIONS. SINCE THE VENTILATOR UNDERGOES MANDATORY VALIDATION BEFORE EVERY USE, ANY DEVICE THAT DOES NOT START WILL SIMPLY BE IDENTIFIED AS NON-OPERATIONAL AND REPLACED OR SERVICED BEFORE IT CAN BE CONSIDERED FOR PATIENT CARE. THEREFORE, THIS IS NOT CONSIDERED A REPORTABLE EVENT. LOCAL BIOMED IDENTIFIED EXPIRATORY VALVE ASSEMBLY AS DEFECTIVE. AFTER EXCHANGING THE EXPIRATORY VALVE ASSEMBLY, THE DEVICE PASSED THE TESTS AND FUNCTIONED AS INTENDED. THIS CASE IS CONSIDERED AS CLOSED.