|
Device Problem
Degraded (1153)
|
Patient Problems
Dyspnea (1816); Headache (1880); Vomiting (2144); Dizziness (2194); Epistaxis (4458); Swelling/ Edema (4577)
|
Event Date 07/30/2021 |
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 bad headaches, dizzy, vomiting, bloody nose , face swelling, breathing problem.There was no report of patient serious 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 visualization of particles related to a cpap device's sound abatement foam.The patient has alleged having bad headaches, dizzy, vomiting, bloody nose , face swelling, breathing problem.There was no report of patient harm or injury.After the first attempt to have the device and components returned for evaluation, the customer stated that i don't want the replacement but i want the reimbursement.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.
|
|
Search Alerts/Recalls
|
|
|