(b)(4).Method: the complaint iw980 wall mount infant warmer was returned to fisher & paykel healthcare (f&p) service centre in (b)(4) where it was visually inspected by a trained f&p service technician.Our investigation is therefore based on the photographs and information provided by the f&p service technician, and our knowledge of the product.Results: visual inspection of the subject iw980 wall mount infant warmer revealed that the head case was found to be cracked.Conclusion: we are unable to determine the cause of the reported event.However, based on our knowledge of the product and this failure mode, the observed damage on the warmer head was likely due to impact damage during transportation.The user manual for the iw980 infant warmer states "ensure all warmer parts and accessories are checked before returning the device to service".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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A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, an issue with a iw980 wall mount infant warmer.Upon servicing of the device at the fisher & paykel healthcare (f&p) service centre in germany, it was discovered that the head case was cracked.There was no patient involvement.
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