Resmed has requested for the mask to be returned so that an engineering investigation can be performed.The mask has been disposed of and therefore, not available to be returned to resmed for evaluation.On november 20, 2023, a field safety notice was issued by resmed (mwm-2023-fsn-01) for all lots of resmed masks with magnets: airfit n10, airfit n10 for her, airfit n20, airfit n20 for her, airtouch n20, airtouch n20 for her, airfit f20, airfit f20 for her, airfit f20 nv, airtouch f20, airtouch f20 for her, airfit f30, airfit f30i.Resmed has updated the contraindications and warnings in our mask with magnets¿ user guides so clinicians and patients aware of the potential risks associated with the magnetic fields and to take precautionary measures when using the mask.Corrective and preventative actions are being taken by resmed to resolve the issue.Mcapa-1637.Resmed reference#: (b)(4).
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It was reported to resmed that an airfit n20 mask allegedly caused magnetic interference with a patient¿s ¿medtronic model shunt", causing the shunt to malfunction.Attempts were made to obtain additional information regarding the type of shunt used by the patient.No information has been received to date.The patient felt dizzy, was passing out and couldn¿t walk in straight line over the next 3 weeks.The patient also experienced pressure headaches.It was reported that the shunt kept switching settings and the patient had to undergo a revision surgery for the shunt.
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