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Model Number DSX500S11 |
Device Problem
Degraded (1153)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device has yet to be returned for evaluation.
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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 customer has alleged visualization of black foam particulate in the heated tubing of the device.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 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 an issue related to a cpap device's sound abatement foam.The customer has alleged visualization of black foam particulate in the heated tubing of the device.There was no report of patient harm or injury.Update: the device was returned to a third party service center.An evaluation was performed and no foam particles were found in the device.No error codes were present.The device was scrapped.
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Search Alerts/Recalls
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