(b)(4).Method: the complaint 900mr810 evatherm circuits (1x lot 130700 & 1 x lot 130800) were returned to fisher & paykel healthcare in new zealand and were visually inspected.Results: visual inspection of both devices revealed a 3 mm tear in the film of the heated reusable tube, next to the chamber end over-moulded cuff.A lot check revealed no other complaints of this type for either lot number provided.Conclusion: we were unable to determine what has caused the observed damage.The damage may have been caused by improper cleaning or rough handling of the circuits.The customer had reported that the circuit failed after five to ten uses, which shows the damage occurred after it was released for distribution.The user instructions that accompany the 900mr810 clearly state: -"clean circuit prior to use and after each patient use, using approved disinfection methods only." -"inspect circuit before re-use, do not use if circuit shows signs of deterioration, such as: cracks, tears, or damage." -"disconnect tube by handling end connectors only, do not pull or twist tubing, as this may cause damage.".
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