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Model Number DSX500T11 |
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 : device 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 black particles blowing out of device, noisy.There is no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.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 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 black particles.There is no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.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.In box e, initial reporter: reporter country is updated and in box g, all manufacturers: report source is updated in this follow-up.
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Search Alerts/Recalls
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