Model Number 27011 |
Device Problem
Defective Device (2588)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/16/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned to resmed and an evaluation confirmed the complaint.The non-return valve (nrv) assembly was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.(b)(4).
|
|
Event Description
|
It was reported to resmed during evaluation that an astral device had a defective non-return valve (nrv) assembly.There was no patient harm or serious injury reported as a result of this incident.
|
|
Event Description
|
It was reported to resmed that an astral device had failed to complete its internal self-test.There was no patient harm or serious injury reported as a result of this incident.
|
|
Manufacturer Narrative
|
Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to a design specification limitation.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).
|
|
Search Alerts/Recalls
|