|
Model Number DNX500H11C |
Device Problem
Degraded (1153)
|
Patient Problems
Cardiac Arrest (1762); Cough (4457)
|
Event Date 08/01/2022 |
Event Type
Injury
|
Event Description
|
The manufacturer received information alleging cough, device will not turn on/device not functioning related to a cpap device's sound abatement foam.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 previously reported information in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.Additional information was received that the patient is now alleging a heart attack while using the device, which would change this report to a serious injury.Medical intervention was hospitalization.
|
|
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 heart attack.The patient also alleged cough, device will not turn on / device not functioning, device not delivering proper pressure.The patient did report to receive medical intervention and was hospitalized.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
|
|
|