|
Device Problem
Degraded (1153)
|
Patient Problems
Cancer (3262); Unspecified Gastrointestinal Problem (4491)
|
Event Date 03/21/2024 |
Event Type
Injury
|
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 is alleging cancer and gastrointestinal stromal tumor.At this time, no medical intervention has been reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|
|
Manufacturer Narrative
|
Since 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.
|
|
Search Alerts/Recalls
|
|
|