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Device Problem
Degraded (1153)
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Patient Problems
Asthma (1726); Pulmonary Dysfunction (2019)
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Event Date 03/31/2023 |
Event Type
Injury
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Manufacturer Narrative
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Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.
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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 reported using one of the dreamstation cpap machines continuously for 4 years prior to the recall.The patient alleges to have developed lung issues and asthma as a result of non-use of the device while waiting on a replacement for approximately 4 months.The patient felt that it was necessary to purchase another device out-of-pocket in lieu of waiting any longer on the replacement device to avoid a worsening health condition.No patient information was provided.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.
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Search Alerts/Recalls
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