Device Labeling - Medtronic Ventilator Files (Risk Management documents)

#1
Hello everyone.

I was curious about the tech file released by Medtronic to build the PB560 ventilator. As soon as I got the files I digged in to find the RMF. Apparently they only released a FMEA chart with some additional elements to address ISO 14971 requirements.

I'm a bit suprised to find multiple instances in which labeling is being used as protective measures and in some cases labeling is even considered to provide inherent safety.

Has someone else checked Medtronic's files?

Stay safe!
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Please remember that Medtronic documents and files are company confidential so any discussion should be kept very general and no files may be shared here.

Thanks!
 

yodon

Staff member
Super Moderator
#3
I believe those files were made public by Medtronic as a COVID response, in an attempt to enable others to build ventilators without the long design cycle. FDA is working with companies to get devices released under "Emergency Use Authorization" that don't fully comply with regulatory requirements or relevant standards. The companies have to prove they're 'good enough' and 'safe enough' to use. A bit scary, but I guess it beats not having any options.

I've not looked at the files but I'm guessing a) they didn't put everything out; and b) it may be an old design and the risk file never updated (not to imply that's right or anything).
 
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