RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900T11C |
Device Problem
Degraded (1153)
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Patient Problems
Angina (1710); Headache (1880); Numbness (2415); Respiratory Tract Infection (2420)
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Event Date 10/05/2021 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged seeing black stuff all over his mouth.The patient alleged having sinus, headaches, chest pains and numbness in legs.There was no report of patient harm or injury.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 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 previously received information the patient alleged seeing black stuff all over his mouth.The patient alleged having sinus, headaches, chest pains and numbness in legs.Related to a cpap device's sound abatement foam.There was no report of patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h6 updated in this report.
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Manufacturer Narrative
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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 previously reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged visualization of particles.The patient alleged having sinus, headaches, chest pains and numbness in legs.There was no report of serious or permanent harm or injury.Additional information was received and added to the report.The device was returned to the manufacturer's service center on 03/29/2023 for further evaluation.The device was evaluated on 05/26/2023.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit scrapped due to age.Section d8, d9, h2, h3 and h6 were updated.
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