(b)(4).Method: the complaint iw990 infant warmer was received at fisher & paykel healthcare (fph) office in the (b)(4), where it was inspected by a trained fph service engineer.The control and power pcb board of the complaint infant warmer was sent to fph (b)(4) for investigation.The pcb board was performance tested by inserting it into a working infant warmer unit.Results: when power was applied, the test infant warmer powered up and worked normally; however, the power fail alarm did not operate when the power at the supply wall outlet was switched off.Continuity testing of the supercapacitor on the power pcb board revealed that the connection of the supercap terminal was open circuit.A lot check revealed no other complaint of this nature for the affected lot.Conclusion: the subject infant warmer unit is nearly 16 years old and it is likely that the replaceable super capacitor on the pcb board had simply worn out.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 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.The customer decided to purchase a new iw990 infant warmer and to discard the complaint unit, as the complaint unit is already 16 years old.
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