|
Device Problem
Degraded (1153)
|
Patient Problems
Atrial Fibrillation (1729); Unspecified Respiratory Problem (4464)
|
Event Date 03/21/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
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.H3 other text : device not returned to the manufacturer.
|
|
Event Description
|
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 has alleged nose irritation, atrial fibrillation.Medical intervention was not specified.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|
|
Search Alerts/Recalls
|
|
|