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Model Number DS660HS |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Headache (1880); Red Eye(s) (2038); Dizziness (2194); Unspecified Respiratory Problem (4464)
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Event Date 07/29/2021 |
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 respiratory issues, congestion, dizziness, red eyes, runny nose and headaches, difficulty breathing/short of breath.There was no report of serious 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 of respiratory issues, congestion, dizziness, red eyes, runny nose and headaches, difficulty breathing / short of breath 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 a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Sections d1, d4, h4 and h6 updated in this report.
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Search Alerts/Recalls
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