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Model Number DS560HS |
Device Problem
Degraded (1153)
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Patient Problems
Pulmonary Hypertension (4460); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3 other text : device not returned to manufacturer.
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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 mask, tubing, and on pillow.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 mask, tubing, and on pillow.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient. on the previously submitted report, the reporter address in section e was inadvertently left blank. it is corrected on this report.
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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 mask, tubing, and on pillow.The patient alleges pulmonary hypertension.Due to clinical expert decision, this report will now be filed as an adverse event.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Search Alerts/Recalls
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