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Model Number DS550HS |
Device Problems
Contamination (1120); Degraded (1153)
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Patient Problems
Headache (1880); Eye Pain (4467)
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Event Date 07/20/2021 |
Event Type
malfunction
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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 cpap device's sound abatement foam.The patient has alleged headache.There was no report of serious 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 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 an issue related to a cpap device's sound abatement foam.The patient has alleged headache.There was no report of serious 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.Section h4-device manufacturer date, d4-additional device information were not captured in previous report and those have been updated/corrected in this report.Section h6 updated in this 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 received information alleging headache, pain behind one of his eyes going to back of his head related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.Pil observed an unknown dust/dirt contamination present in airpath on side panel outlet, unknown debris contamination under ui knob, and unknown dust/dirt contamination at sd card insert.Internal investigation of base unit found unknown dust/dirt/fiber contamination throughout the device internals and unknown residue under ui knob.There is a collection on unknown dust/dirt contamination built up at ui knob location on pca.Evidence of the start of sound abatement foam degradation/breakdown was observed in this device.Pil is unable directly address the symptoms outlined in the complaint.Pil can confirm that there was evidence of sound abatement foam degradation/breakdown observed in the base unit.The device was hooked up to a known good power supply and power cord, airflow was verified to be operating correctly.The error log showed that there were 32 instance of errors on the device.Pil was able to confirm the presence of degraded sound abatement foam in the device.Evidence of dust contamination observed.Section d8, d9, g3 has been updated.Section h6 has been updated.
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Search Alerts/Recalls
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