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Device Problem
Degraded (1153)
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Patient Problems
Cough (4457); Epistaxis (4458); Unspecified Respiratory Problem (4464)
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Event Date 08/09/2021 |
Event Type
malfunction
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Event Description
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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 coughing, nose irritation, and bleeding from using the device.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.The device has not yet been returned to the manufacturer for evaluation and there is no contact information for the initial reporter to gain additional information on the device.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.
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Manufacturer Narrative
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H3 other text : the device has not been returned to the manufacturer.
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Manufacturer Narrative
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The manufacturer previously reported information 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 coughing, nose irritation, and bleeding from using the device.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.The device has not yet been returned to the manufacturer for evaluation and there is no contact information for the initial reporter to gain additional information on the device.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.On the initial report, the reporter country was omitted.It has been corrected on this report.
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Search Alerts/Recalls
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