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Model Number DS660HS |
Device Problem
Degraded (1153)
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Patient Problems
Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457); Wheezing (4463)
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Event Date 10/26/2021 |
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/bipap) device's sound abatement foam.The patient has alleged coughing, wheezing, nasal irritation, sore throat.There was no report of serious or permanent 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 coughing, wheezing and nasal/throat irritation or soreness related to a bipap device's sound abatement foam.There was no report of patient harm or injury.Section b4 (date of this report) corrected to 18-may-2023 which was incorrect (17-may-2023) in previous report.
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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 coughing, wheezing and 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 final 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 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.
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Search Alerts/Recalls
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