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Model Number AH560HS |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Red Eye(s) (2038); Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457); Unspecified Respiratory Problem (4464)
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Event Date 09/17/2021 |
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 nasal/throat irritation or soreness, coughing, nose is dry, red spot in her eye and chest feels have and she feels tired, skin is dry.There was no report of patient serious 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 nasal/throat irritation or soreness, coughing, nose is dry, red spot in her eye and chest feels have and she feels tired, skin is dry 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 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.Section h6 updated in this report.
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Search Alerts/Recalls
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