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Model Number DNX500H11C |
Device Problems
Degraded (1153); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2022 |
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 patient has alleged to air pressure giving too little or too much air.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The device was returned but not yet evaluated.The investigation is on-going.A final report will be submitted when the investigation is complete.
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Manufacturer Narrative
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H3 other text : device has been received, evaluation has not yet begun.
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Search Alerts/Recalls
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