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Model Number RGBX1030S20 |
Device Problems
Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2024 |
Event Type
Death
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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 death.There was report of serious or permanent harm or injury.Device has not been returned to the manufacture for evaluation.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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H3 other text : device not returned to manufacturer.
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Manufacturer Narrative
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Initial report was submitted as a part of uno recall device, the device is not under the uno recall.Correct event description should be - the manufacturer received information regarding a rental-dreamstation auto cpap.The patient has passed away.The manufacture's investigation is ongoing.A follow up report will be submitted.In this report box h has been updated/corrected.
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Search Alerts/Recalls
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