(b)(4).Method: the complaint iw990 infant warmer was serviced by a trained f&p technician on site at the healthcare facility.Results: during the service, it was noted that the unit's power fail alarm did not function when the unit was disconnected from power.The fault was traced to the failure of a capacitor on the pcb.Conclusion: the subject iw990 infant warmer was released for distribution in 2004 and thus is over 14 years old.It is likely that the replaceable super capacitor on the pcb wore out over time.The super capacitor's function is to store sufficient electrical charge to power the warmer's visual and audible alarms in the event of a failure of mains power.Part of fisher & paykel healthcare's quality control process involves testing the power failure alarm of every warmer on the production line for functionality prior to distribution.The device technical/service manual contains a checklist which specifies that users perform safety, performance and functional checks including the power fail alarm at least once a year.Included in the warmer's maintenance checklist is a test of the super capacitor to ensure it is operating within specifications.
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