The manufacturer was contacted regarding 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 from the patient, alleging that the patient has pneumonia and irritation.No medical intervention was specified.The manufacturer was made aware of this information through the customer's legal representative.Due to potential litigation surrounding this case, no further investigation or follow-up can be carried out.If any additional information is received, a follow-up report will be filed.
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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 : the device has not been returned to the manufacturer for analysis.
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