RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900T11C |
Device Problem
Degraded (1153)
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Patient Problems
Cancer (3262); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2022 |
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 an issue related to a bipap device's sound abatement foam.The patient has alleged visualization of particle.There was no report of 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 previously received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged visualization of particles.There was no report of patient harm or injury.The manufacturer received new information of patient has medical history of cancer.In this report, section g3 has been updated or corrected.
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Manufacturer Narrative
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The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and 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 manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged to visualization of particle.There was no medical intervention required by the patient.The reported event of visualization of particle and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient. the device has not yet returned to the manufacturer for evaluation.The patient has swapped out the deice at the distributor and at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.The manufacturer previously not captured operator of the device-section d5 and it has been updated in this report.Section(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.
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Manufacturer Narrative
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The manufacturer previously submitted mdr with incorrect sections b1, b2, h1, h6.Corrections to previous mdr are made in this report as follows section b1 was corrected to adverse event (product problem was checked in initial mdr) section b2 was corrected to other serious or important medical events.(previously it was blank) section h1 was changed from malfunction to serious injury.In this report, health effect - impact code has been updated or corrected.
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Search Alerts/Recalls
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