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Model Number DSX600H11C |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Dizziness (2194); Eye Burn (2523); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged visualisation of black particles, there is no allegation of serious or permanent 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 previously reported receiving information alleging an issue related to the bipap device's sound abatement foam.The patient alleged shortness of breath, dizziness, eye burning.Section h6 health effect - clinical code: 1816, 2194, 2523 was missing in the previous report, which is correctly updated in this follow-up report.
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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 alleged shortness of breath, dizziness and eye burning 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.
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Search Alerts/Recalls
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