|
Model Number DSX500H11C |
Device Problem
Degraded (1153)
|
Patient Problems
Headache (1880); Sore Throat (2396); Respiratory Tract Infection (2420); Swollen Lymph Nodes/Glands (4432); Unspecified Respiratory Problem (4464); Swelling/ Edema (4577)
|
Event Date 10/25/2021 |
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 and mechanical ventilator devices.The manufacturer received information alleging sinus infection, swollen face, infected lymph node, sinus draining, headaches, sore throat.There was no report of patient serious harm or injury.The device was returned and passed all the test during evaluation.
|
|
Manufacturer Narrative
|
The manufacturer previously reported an allegation of an issue related to sound abatement foam.Upon further review, this device was a repaired device and did not contain sound abatement foam that would be likely to cause or contribute to death or serious injury and is not in scope of res 88058.Therefore, there is no allegation of a reportable event associated with the device at this time.
|
|
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 sinus infection, swollen face, infected lymph node, sinus draining, headaches,sore throat.Related to a cpap device's sound abatement foam.There was no report of patient serious harm or injury.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated and and no contamination was observed in the device.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no error found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Section d8, d9, h2, h3 and h6 were updated.
|
|
Search Alerts/Recalls
|
|
|