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Model Number DSX400H11C |
Device Problem
Degraded (1153)
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Patient Problems
Arrhythmia (1721); Bacterial Infection (1735); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Convulsion/Seizure (4406); Unspecified Immune System Problem (4435); Unspecified Heart Problem (4454); Wheezing (4463); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2023 |
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 visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.No medical intervention was 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 previously reported information 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 visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Additional information received from the patient alleging heart issue, difficulty breathing, gasping, tuberculosis, and immune system issue.
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Manufacturer Narrative
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The manufacturer previously reported an allegation of an issue related to sound abatement foam.Correction section b5 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 patient alleging visualization of particles in the air path, heart issue, difficulty breathing, gasping, tuberculosis, and immune system issue,hypertension,heart arrhythmia while also suffering from major vitamin d deficiency, sleep deprivation, joint, skeletal, and muscle pain; as well as neurological issues causing him to have seizures.The reported event of alleges heart issues and its reported severity was reviewed by the manufacture¿s clinical expert.This event is assessed as serious injury.There was no medical intervention required by the patient.The device has not yet returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.Section(s) b1, b2, has changed related to the complaint changing from the reported product problem to adverse event.Section h1 has changed to reflect a serious injury.Section h6 health effect- impact code has been updated.
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Search Alerts/Recalls
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