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Model Number DS960XHS |
Device Problem
Degraded (1153)
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Patient Problems
Dry Eye(s) (1814); Dyspnea (1816); Memory Loss/Impairment (1958); Sore Throat (2396); Respiratory Tract Infection (2420); Dry Mouth (4485); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/28/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging dry throat and nasal,sinus infections,dry eyes,difficulty breathing,shortness of breath, memory loss, device is noisy, nasal/throat irritation or soreness related to a bipap device's sound abatement foam.There was no report of 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 allegation issue related to a bipap device's sound abatement foam.The patient alleged dry throat and nasal,sinus infections,dry eyes,difficulty breathing,shortness of breath,memory loss,device is noisy,nasal/throat irritation or soreness.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.
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Search Alerts/Recalls
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