N
Patient 1
(B)(4). METHOD: THE COMPLAINT PT101 AIRVO 2 HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN (B)(4) AND WAS INSPECTED BY A TRAINED F&P TECHNICIAN. THE DEVICE WAS PERFORMANCE TESTED AND THE AUDIBLE ALARM FUNCTION WAS CHECKED. THE DEVICE WAS THEN DISPOSED OF. RESULTS: DURING TESTING IT WAS FOUND THAT THE AUDIBLE ALARM DID NOT FUNCTION. PREVIOUS INVESTIGATIONS INTO THIS TYPE OF FAILURE HAVE IDENTIFIED THAT THE PROBLEM IS CAUSED BY A FAULTY SPEAKER AND ELECTRICAL RESISTANCE TESTING HAS SHOWN THE SPEAKER'S RESISTANCE TO BE OPEN CIRCUIT. CONCLUSION: AS PART OF OUR ONGOING PRODUCT IMPROVEMENT INITIATIVES, WE HAVE IMPLEMENTED A SOAK TEST FOR 100% TESTING OF THE SPEAKER HARNESS ON THE AIRVO PRODUCTION LINE, WHICH IDENTIFIES AND DISCARDS ANY FAULTY SPEAKERS PRIOR TO ASSEMBLY INTO THE AIRVO. ADDITIONALLY, A NEW SPEAKER UNIT HAS MORE RECENTLY BEEN SOURCED FROM A DIFFERENT SUPPLIER. THE SUBJECT AIRVO WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF BOTH THESE MEASURES. THE AIRVO USER MANUAL STATES THAT THE "AIRVO IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH-FLOW, WARMED AND HUMIDIFIED RESPIRATORY GASES" AND THAT "THE UNIT IS NOT INTENDED FOR LIFE SUPPORT." THE USER MANUAL WARNS THE USER: PRIOR TO EACH PATIENT USE, ENSURE THAT THE AUDITORY ALARM SIGNAL IS AUDIBLE BY CONDUCTING THE ALARM SYSTEM FUNCTIONALITY CHECK DESCRIBED IN THE ALARMS SECTION. THE ALARM SYSTEM FUNCTIONALITY CHECK INSTRUCTS THE USER ON HOW TO TEST THE ALARM AND STATES THAT "IF EITHER ALARM SIGNAL IS ABSENT, DO NOT USE THE UNIT. CONTACT YOUR FISHER & PAYKEL HEALTHCARE REPRESENTATIVE."