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Model Number DSX500T11 |
Device Problem
Degraded (1153)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Unspecified Heart Problem (4454)
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Event Date 09/25/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3 other text : device not returned to the manufacturer for evaluation.
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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 cpap device's sound abatement foam.The patient alleged that some black particles are blowing from the device, heart disease, and high blood pressure after using the device.Medical intervention was not specified. 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 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 an issue related to a cpap device's sound abatement foam.The patient has alleged that black particles are blowing from the device, heart disease, and high blood pressure after using the device.Medical intervention was not specified.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.
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Search Alerts/Recalls
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