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Model Number DSX500T11 |
Device Problem
Degraded (1153)
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Patient Problems
Hearing Impairment (1881); Vertigo (2134); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/30/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3 other text : device not returned to 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 rhinitis medicamentosa, sensorineural hearing loss, vertigo, sinus infection, and chronic throat clearing.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.
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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 rhinitis medicamentosa, sensorineural hearing loss, vertigo, sinus infection, and chronic throat clearing.Medical intervention was not specified.The following sections were corrected: b1, b2, h1, h6.The adverse event/product problem was initially reported as an product only, but is now corrected to both to include adverse event.Other is now selected as the outcome of adverse.The type of reportable event was initially reported as product problem.The correct type of reportable event is serious injury.The health impact grid was initially coded for c50675 (no health consequences or impact).The correct code is c172031 (serious injury/illness/impairment).
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Search Alerts/Recalls
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