(b)(4).Method: the complaint icon cpap was received at fisher and paykel healthcare in (b)(4) for evaluation.The icon cpap was inspected externally.Results: visual inspection revealed no signs of impact damage to the returned cpap.The power cord was observed to be cut.The device's hour meter read 1,638 hours, indicating it had been used for approximately 200 days.A lot check revealed no other complaints of damaged power cords for lot number 140806.Conclusion: from the investigation conducted, the nature of the damage observed on the power cord suggests that it was cut.It is unknown how the cord became cut, however based on the number of hours used before a complaint was noted, the cut most likely occurred when in use by the customer.During initial assembly of the icon cpap, all power cords are visually inspected for damage.Once the assembly process is completed, all icon cpap devices are visually inspected again before release for distribution.This suggests the damage occured after it had been distributed.The icon cpap is designed to the electrical safety standards ,ul60601-1 and as/nzs 3200.1.The materials used in the thermoplastic components of the mains connector and the cases are flame retardant according to ul 60601-1 and as/nzs 3200.1.Our user instructions that accompany the icon state the following: only operate if the device, power cord and plug are dry and in good working order.Do not operate the device, water chamber or breathing tube if it is dropped, damaged or not working as intended.
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