Model Number DSX500T11C |
Device Problem
Degraded (1153)
|
Patient Problem
Convulsion/Seizure (4406)
|
Event Date 10/22/2021 |
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 alleged patient to having more seizures than normal so she really needs her new machine.There was no report of serious or permanent 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 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 (b)(4).Therefore, there is no allegation of a reportable event associated with the device at this time.
|
|
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.As per the additional information there is a serious injury but ,this not related to the device.In this report d9 and h3 sections are updated.
|
|
Search Alerts/Recalls
|