RESPIRONICS, INC. DREAMSTATION AUTO BIPAP W/HUM/CELL, DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
|
Back to Search Results |
|
Model Number DSX700H11C |
Device Problem
Degraded (1153)
|
Patient Problems
Dyspnea (1816); Eye Infections (4466)
|
Event Date 11/03/2022 |
Event Type
malfunction
|
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 to having difficulty breathing/short of breath. there was no report of 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 difficulty breathing/short of breath related to a cpap device's sound abatement foam.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.Section h6 updated in this report.
|
|
Manufacturer Narrative
|
The manufacturer previously reported an allegation of an issue related to sound abatement foam.A correction to b5 was made and should be: 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 difficulty breathing/shortness of breath, eye irritiation, not getting enough oxygen, device has strange taste, related to a bipap device's sound abatement foam.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 an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 corrected in this report.
|
|
Search Alerts/Recalls
|
|
|