RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV H, DS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900H11 |
Device Problems
Degraded (1153); Inaccurate Delivery (2339); Detachment of Device or Device Component (2907)
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Patient Problems
Unspecified Mental, Emotional or Behavioural Problem (4430); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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H3 other text : not returned.
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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.Patient's wife ruby beck states patient (b)(6) has alzheimer's disease.His machine is not working properly.The door on the humidifier will not stay closed, if he is sleeping and it opens in the middle of the night, they hear a flood of air.Then he is not getting the appropriate amount of pressure in his mask.There is no allegation of serious or permanent harm or injury.No medical intervention was required 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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Correction in the following fields: box b adverse event/product problem -adverse event outcomes attributed to ae -required intervention type of reported complaint -serious injury device problem code: dpr-ppi-03 material integrity problem dpr-ppi-03-05 degraded patient outcoe code grid *pao-gen-02-12 - unspecified mental, emotional or behavioural problem *health impact fda c-code - c172050 health impact grid *hi-gen-12- serious injury/illness/impairment *health impact fda c-code - c172031.
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Search Alerts/Recalls
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