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Model Number DSX520H11C |
Device Problems
Degraded (1153); Patient Device Interaction Problem (4001)
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Patient Problems
Asthma (1726); Hypersensitivity/Allergic reaction (1907); Unspecified Respiratory Problem (4464); Dry Mouth (4485)
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Event Date 10/06/2023 |
Event Type
Injury
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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 alleged latex of the device, running nose and very dry mouth, very horse, lots of mucus, clear in color related to a ds2adv auto cpap sound abatement foam.The patient reported medical intervention.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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The manufacturer previously reported this device under recall z-1973-2021.After further review, the manufacturer concluded the reported device is not under recall.In box b, describe an event or problem that should be reported as: the manufacturer was contacted in reference to the voluntary field safety notice related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleged latex of the device, running nose and very dry mouth, very horse, lots of mucus, clear in color related to a ds2adv auto cpap sound abatement foam.The patient reported medical intervention.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 previous mdrs stated this event was a product problem only.This mdr corrects the event to a serious injury and updates the coding to accurately reflect customer reported event.Device not returned to manufacturer.
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Event Description
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The manufacturer received information alleging that the patient is allergic to something with the device.She has a runny nose, very dry mouth very horse, lots of mucus and clear in color.Additionally, the patient is allergic to latex, and she has asthma.The patient has been to the breathing doctor and got medications as medical intervention.The patient stated she uses johnson baby shampoo and washes daily the device daily as cleaning method.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Search Alerts/Recalls
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