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Model Number 550P |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Hypoxia (1918); Dizziness (2194); Cough (4457); Unspecified Respiratory Problem (4464)
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Event Date 10/01/2021 |
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 dizzy, cough, irritation of throat, breathing issue, lack of oxygen.There was no report of patient harm or injury.There was no medical intervention required by the patient.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 dizzy, cough, irritation of throat, breathing issue, lack of oxygen related to a cpap device's sound abatement foam.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 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.Corrected information provided in section d5.Section h6 updated in this report.
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Search Alerts/Recalls
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