|
Device Problem
Degraded (1153)
|
Patient Problems
Liver Damage/Dysfunction (1954); Cancer (3262)
|
Event Date 02/19/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
No device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972, z-1973 and z-1974.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 manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged liver disease and liver cancer.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|
|
Search Alerts/Recalls
|
|
|