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 eye irritation, nose irritation, respiratory tract irritation, dizziness and/or headache, hypersensitivity, nausea / vomiting, asthma (new or worsening), inflammatory response, kidney disease/toxicity, reduced cardiopulmonary reserve, recurring pneumonia, worsening asthma, sinus inflammation, fluid and scarred tissues in his lungs.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
|
Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : device not returned to manufacturer.
|