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Device Problem
Degraded (1153)
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Patient Problems
Speech Disorder (4415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/01/2021 |
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 voluntary medwatch (mw5113057) alleging an issue related to a continuous positive airway pressure (cpap) device.The patient has alleged speech disorder and had another scraping of his esophagus, went to the er and they did the scraping where not only polyps were attached to the esophagus, attached to his adenoids and came back malignant and spent 4 days in hospital while using this device.Medical intervention was not specified.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 reported an allegation of speech disorder and had another scraping of his esophagus, went to the er and they did the scraping where not only polyps were attached to the esophagus, attached to his adenoids and came back malignant and spent 4 days in hospital while using this device.The medical intervention that the patient received in response to the event is currently unknown.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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