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Device Problem
Degraded (1153)
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Patient Problems
Pneumonia (2011); Sore Throat (2396)
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Event Date 08/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 : device has not been yet returned to the manufacturer.
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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 an issue related to a philips cpap device's sound abatement foam.The patient has alleged swollen throat, pneumonia.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Manufacturer Narrative
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The manufacturer previously reported 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 an issue related to a philips cpap device's sound abatement foam.The patient has alleged swollen throat, pneumonia.There was no serious harm or injury reported.After receiving further information from the patient it is determined that the initial report should have been filed as product problem only.Section adverse event/product problem in box b, section type of reported complaint and health impact grid in box h has been updated/corrected in this report.
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Search Alerts/Recalls
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