Resmed has requested for the products to be returned so that an engineering investigation could be performed.The products have not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.The reportable event occurred outside the us.During a routine check of complaints records it was detected that the event is reportable in the us.This report is being submitted to correct the error.(b)(4).
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It was reported to resmed that during use of airfit f30 full face masks, 'non-vented mask' alarms are occurring.It was reported visual inspection of the quiet air vent of the masks revealed blockage (hair, build-up, etc.).There was no reported patient harm or an injury as a result of this incident.
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