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 patient alleges worsening cough and sleeplessness.Patient is now on oxygen.Device was giving too much pressure and power fluctuation was observed.The patient also complained of fatigue.There is no allegation of serious or permanent harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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