RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900H11C |
Device Problem
Degraded (1153)
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Patient Problems
Cancer (3262); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2022 |
Event Type
Injury
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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 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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Device has yet to be returned for evaluation.
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Manufacturer Narrative
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The manufacturer previously reported 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 bipap device's sound abatement foam.The manufacturer received information alleging throat and lung cancer.After receiving further information from the patient, it is determined that the initial report should have been filed as serious injury only.Section adverse event/product problem in box b, type of reported complaint, patient outcome code grid (1) and health impact grid (1) has been updated/corrected in this report.
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Search Alerts/Recalls
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