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Model Number DSG500S11 |
Device Problems
Degraded (1153); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3 other text : 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 an issue related to a dreamstation go auto device's sound abatement foam.The patient has alleged some black particles are blowing out from the device and it is quite noisy during operation.No serious patient harm or injury reported.The device has not yet been returned to the manufacturer for investigation.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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