The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging device blows hard.The air comes out too much around the sides of the mask.The mask that was purchased by the patient has been giving him problems.The device will not turn on/device not functioning.The patient alleges dry mouth, nasal/throat irritation or soreness and irritation around his eyes.There was no allegation of serious or permanent harm or injury.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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