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Patient 1
(B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. THE HOSPITAL HAD INFORMED US THAT THE HEATED BREATHING TUBE (HBT) USED WAS AN 900PT500, WHICH IS USED WITH THE F&P AIRVO HEATED HUMIDIFIER. THE 900PT500 HBT FORMS A TIGHT FIT WITH THE OPT970 INTERFACE AND REQUIRES OVER 10 NEWTONS OF FORCE IN ORDER TO DISCONNECT IT FROM THE INTERFACE. THE USER INTSRUCTIONS (UI) FOR THE AIRVO 2 SYSTEM SPECIFICALLY WARN THAT THE AIRVO2 "IS NOT INTENDED FOR LIFE SUPPORT" AND THAT "APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES". THE UI ALSO INSTRUCTS THE CAREGIVER TO "USE CONTINUOUS OXYGEN MONITORING ON PATIENTS WHO WOULD DESATURATE SIGNIFICANTLY IN THE EVENT OF DISRUPTION TO THEIR OXYGEN SUPPLY." ALL OPTIFLOW INTERFACES ARE INSPECTED DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLOURATION AND STRETCHING OR DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS DISPOSED OF. THE SETUP INSTRUCTIONS IN THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPT970 ALSO WARN THAT "APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT MAY RESULT IN LOSS OF THERAPY, SERIOUS INJURY OR DEATH."