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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Asthma (1726); Dyspnea (1816); Liver Damage/Dysfunction (1954); Rash (2033); Excessive Tear Production (2235); Speech Disorder (4415); Cough (4457); Renal Impairment (4499)
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Event Date 07/23/2021 |
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, and mechanical ventilator devices.The manufacturer received information alleging hoarse voice, short of breath, asthma, use inhaler, eyes are running, cough, rash, liver and kidney problems.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 hoarse voice, short of breath, asthma, use inhaler, eyes are running, cough, rash, liver and kidney problems related to a cpap 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.Section h6 updated in this report.
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Search Alerts/Recalls
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