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Model Number DNX500H11C |
Device Problems
Contamination (1120); Degraded (1153)
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Patient Problems
Dyspnea (1816); Pulmonary Edema (2020); Unspecified Respiratory Problem (4464)
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Event Date 12/15/2021 |
Event Type
Injury
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Event Description
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The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused.The patient did not report to receive any medical intervention.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
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Manufacturer Narrative
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Additional information and corrected data added to section(s): b(5) narrative and h(6) clinical code added.
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Event Description
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The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused difficulty breathing, fluid within the lungs and scar tissue in the lungs.The patient did not report to receive any medical intervention.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
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Manufacturer Narrative
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The manufacturer was previously 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 cpap device's sound abatement foam.The patient alleged of having difficulty breathing, fluid within the lungs and scar tissue in the lungs.The patient did not report to receive any medical intervention.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection of the device was completed by the manufacturer and found evidence of an unknown dark contaminant, brown sticky congealed substance and dust contaminant on the front panel, edge of the bottom enclosure, blower seal, and on the outlet of the blower box.The manufacturer found no evidence of sound abatement foam degradation/breakdown.The manufacturer concludes the contaminates found were consistent with an unknown dark, dust or dirt contaminant and sticky substances, contamination inconsistent with the sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation/breakdown.After further review, the manufacturer confirmed that the previously submitted report was incorrectly filed as adverse event which should have been filed as product problem only.If any additional information is received, a follow up report will be filed.
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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 continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged to experience a not breathing well, fluid and scar in his lungs with associated difficulty breathing/shortness of breath.There was no medical intervention required by the patient.The reported event of difficulty breathing/shortness of breath 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. 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 2518422-2022-00492-3 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 and product problem.(only product problem was checked in previous 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.Section h6- health effect - impact code was updated.
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Search Alerts/Recalls
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