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Model Number DS1060HS |
Device Problem
Degraded (1153)
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Patient Problems
Sore Throat (2396); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464); Dry Mouth (4485)
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Event Date 11/15/2021 |
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 mouth & nose getting dry, nasal/throat irritation or soreness.There was no report of serious patient harm or injury.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 mouth & nose getting dry, nasal/throat irritation or soreness related to a bipap device's sound abatement foam.There was no report of patient harm or injury.After the second attempt to have the device and components returned for evaluation, customer declined to respond to the gfe related questions and terminated the call.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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