|
Model Number DSX500H11C |
Device Problem
Degraded (1153)
|
Patient Problems
Fatigue (1849); Pneumonia (2011); Respiratory Tract Infection (2420)
|
Event Date 08/28/2023 |
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, bipap, and mechanical ventilator devices.The patient alleges sinus infections, fatigue, pneumonia.No medical intervention was specified by the patient.Customer contact information was unavailable to gather additional information for evaluation and investigation.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.The manufacturer received information alleging sinus infections, fatigue, and pneumonia.The patient did not state whether medical intervention was required.A pms clinical expert review made a determination based on information available at the time of this review, that the allegations constitute a serious injury.The device has been returned to the manufacturer and is pending evaluation.Customer contact and device information were unavailable to gather additional information.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|
|
Search Alerts/Recalls
|
|
|