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Model Number DS460TS |
Device Problem
Degraded (1153)
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Patient Problems
Chest Pain (1776); Hemoptysis (1887); Sore Throat (2396); Respiratory Tract Infection (2420)
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Event Date 09/10/2021 |
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 manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to bleeding through throat,chest pain,nasal/throat irritation or soreness.There was no report of patient harm or injury.There was no medical intervention required by the patient.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 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 previously received information alleging bleeding through throat, chest pain, nasal/throat irritation or soreness related to a bipap device's sound abatement foam.There was no report of patient harm or injury.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.Additional information was provided in section d1, d4 and h4.Section h6 updated in this report.
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Search Alerts/Recalls
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