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Device Problem
Degraded (1153)
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Patient Problem
Respiratory Tract Infection (2420)
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Event Date 10/12/2023 |
Event Type
Injury
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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 manufacturer received information alleging respiratory tract irritation.Medical intervention was not specified.No patient information was provided.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.
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Manufacturer Narrative
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Since there is 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.
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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 manufacturer received information alleging respiratory tract irritation.Medical intervention was not specified.No patient information was provided.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.The previously submitted report was sent as a serious injury while it is a product problem.It is corrected on this report and resubmitted as a product problem.
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Search Alerts/Recalls
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