|
Model Number DSX500H11C |
Device Problem
Degraded (1153)
|
Patient Problems
Dyspnea (1816); Headache (1880); Nausea (1970); Dizziness (2194); Sore Throat (2396); Solid Tumour (4552)
|
Event Date 04/15/2022 |
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, and mechanical ventilator devices.The manufacturer received information alleging particles in tubes and airway, a tumor mass in brain, dizzy, headaches, nasal soreness, lightheaded, nausea, difficulty breathing/short of breath.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 an issue related to a cpap device's sound abatement foam became degraded and caused particles in tubes and airway, a tumor mass in brain, dizzy, headaches, nasal soreness, lightheaded, nausea, difficulty breathing/short of breath.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 updated in this report.
|
|
Search Alerts/Recalls
|
|
|