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Model Number DSX500H11 |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Lethargy (2560); Fluid Discharge (2686); Unspecified Respiratory Problem (4464)
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Event Date 08/04/2021 |
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 patient alleges since discontinuing use of device, patient is experiencing lethary, headaches, runny nose and is congested.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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A device was returned to a service center 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 device was not in patient use.During the evaluation of the device, the service center visually inspected the device and found no evidence of foam degradation.During the evaluation, no confirmation of customer complaint.No problem found.The device has been scrapped.
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Search Alerts/Recalls
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