Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.The initial medwatch report was submitted in error under a previous single mdr exemption approval, this resubmission is done to correct the error.Previously submitted medwatch report number 3004604967-2019-00210 / 3007573469-2019-00210.Resmed reference #: (b)(4).
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