|
Device Problem
Degraded (1153)
|
Patient Problems
Chest Pain (1776); Dyspnea (1816)
|
Event Date 10/14/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
At this time the manufacturer was unable to retrieve details regarding the device information.Therefore, possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : the device has not yet been 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 manufacturer received information alleging chest pain, difficulty breathing and shortness of breath.There was no report of serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|
|
Search Alerts/Recalls
|
|
|