|
Model Number CAX400H12 |
Device Problem
Material Disintegration (1177)
|
Patient Problems
Nausea (1970); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 10/13/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
H3 other text : device not returned to 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 alleges major nausea and peeling on the inside of her cheeks that have been going on for a year.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.
|
|
Search Alerts/Recalls
|
|
|