Model Number DS760HS |
Device Problem
Degraded (1153)
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Patient Problems
Pulmonary Emphysema (1832); Chronic Obstructive Pulmonary Disease (COPD) (2237); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/09/2021 |
Event Type
Injury
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Event Description
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The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused chronic obstructive pulmonary disease (copd), emphysema and respiratory distress.The patient alleges that the device has a burning smell and lights up but no power.The patient did not report to receive medical intervention.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 visualization of particles related to a bipap 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.Updated in this report.
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Event Description
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The manufacturer received information alleging visualization of particles related to a bipap device's sound abatement foam.There was no report of patient harm or injury.
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Search Alerts/Recalls
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