(b)(4).Method: the complaint sleepstyle cpap was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection of the sleepstyle cpap confirmed that one of the pins was pulled out from the mains inlet socket (power socket) of a sleepstyle cpap.Conclusion: the reported incident was traced to an issue in the assembly process of the supplied mains inlet socket.The supplier of the mains inlet sockets was notified, and they have made changes to the assembly process.As part of our ongoing product improvement initiatives, a gauge test was implemented which identifies and rejects any potentially faulty mains inlet sockets during the assembly of the sleepstyle.The subject sleepstyle was manufactured prior to implementation of these measures.Our user instructions that accompany the f&p sleepstyle state the following: - "do not use if the device, power cord, or accessories are damaged, deformed or cracked" - "do not pull on the power cord as it may become damaged" - "turn the device off at the power supply, then remove the power cord from the rear of the device".
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