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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Ulcer (2274); Sore Throat (2396); Unspecified Respiratory Problem (4464)
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Event Date 01/14/2022 |
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 and mechanical ventilator devices.The manufacturer received information alleging headache, congestion, respiratory issues, nasal/throat irritation or soreness, nose sore and scabby.There was no report of permanent or serious patient harm or injury.
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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 visualization of particles related to a cpap device's sound abatement foam.The manufacturer also received information alleging headache, congestion, respiratory issues, nasal/throat irritation or soreness, nose sore and scabby.There was no report of patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful as customer hunged up the call.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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