(b)(4).Method: the complaint iw910 mobile infant warmer was not returned to fisher & paykel healthcare for evaluation.Our investigation is based on visual inspection of the photographs provided by the hospital, our knowledge of the product and investigations into similar complaints.Results: visual inspection of the photograph revealed that the harness connector appeared discoloured.A lot check revealed no other complaints of this nature for the lot number provided.The unit was released for distribution in 2003, indicating that the complaint infant warmer is over 12 years old.Conclusion: the upper and lower harness connectors are used to connect the head unit to the control unit of the infant warmer.Previous investigations of similar complaints revealed that the discoloured harness connector of the infant warmer is most likely the result of arcing that occurred between two electrical contacts, due to frequent swivelling of the warmer head, leading to contact failure.The arcing is most likely caused by a poor connection.The infant warmer controller continuously monitors the electrical power delivered to the heating element and when it is detected insufficient due to open circuit or a faulty harness connection, the infant warmer enters a fail-safe state (e17), ceases power to the heating element and then emits an audible and visual alarm.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by (b)(4).The device technical/service manual contains a checklist which specifies that users perform safety, performance and functional checks at least once a year.
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