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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Asthma (1726); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Low Oxygen Saturation (2477); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/18/2021 |
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, and mechanical ventilator devices.The manufacturer received information alleging chest pain, pressure on chest, low stamina, constantly on oxygen, allergy, headache.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 chest pain, pressure on chest, low stamina, constantly on oxygen, allergy,headache 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.Section h6 updated in this report.
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Manufacturer Narrative
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Additional information was received and section h10 should be reported as: 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 chest pain, pressure on chest, low stamina, constantly on oxygen, allergy,headache, difficulty breathing now requiring o2, asthma (new or worsening), lung disease and reduced cardiopulmonary reserve.Related to a cpap device's sound abatement foam.There was no report of patient harm or injury.In this report, health effect - impact code has been updated or corrected.
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Search Alerts/Recalls
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