|
Model Number DSX1130T11C |
Device Problem
Degraded (1153)
|
Patient Problems
Dyspnea (1816); Headache (1880); Dizziness (2194); Respiratory Tract Infection (2420); Cough (4457); Respiratory Insufficiency (4462)
|
Event Date 05/17/2022 |
Event Type
malfunction
|
Event Description
|
The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged sinus congestion, shortness of breath, difficulty in breathing, dizziness, chest congestion, cough and headache.There was no report of permanent or 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.
|
|
Manufacturer Narrative
|
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 previously received information alleging issue related to a bipap device's sound abatement foam and sinus congestion, shortness of breath, difficulty in breathing, dizziness, chest congestion, cough and headache.There was no report of patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
|
|
Search Alerts/Recalls
|
|
|