Query about ventilator problems

we don't use Drager vents....but what you are saying SCARES ME!! I was an RRT long before I was an RN...and you are talking about a HUGE liability issue!! What if they DON'T reboot?? Wouldn't trust that vent as far as I could pick it up and throw it!! Someone (ANYONE) needs to contact the service rep...and find out what is happening?? Software problem?? It needs fixed ASAP!

Believe me, it scares the staff in our unit as well. I won't and can't elaborate for a variety of reasons, but it is certainly being investigated on a number of fronts.

What is frustrating (but unfortunately not unusual) is that Drager tell us we are the only unit suffering from this problem, and therefore it must not be a problem with the ventilator. I respectfully disagree.

I have found a handful of incidents, which look very similar to our problem, reported on the FDA incident reporting website (just search for Evita XL). I suspect that this may only be the tip of an iceberg (Baxter Colleague anyone?) but that is only speculation. That's why I came here, to see if the people who actually use the ventilators have any firsthand experience..

thanks

jasper_x

Why don't you put it in writing in a complaint to the device company (they have to investigate as part of their quality management system), or reporting the incident to the FDA Medwatch? This just ensures something is registered/investigated - trust me, you'll feel worse if someone dies and you didn't do anything.

We use the Drager babylog in the NICU. An x-ray tech once tripped on the power cord and unplugged it. When it was plugged in it rebooted itself quickly and resumed at the proper settings. It just had a "recalibration needed" message. It sounds like there is a disruption from the power source or internal power loss. Seems like something is quite wrong in this case. Take the unit out of service and document the problem.

I don't want to give anyone the impression that we are not doing anything about it. It has been reported to all the relevent authorities and to the manufacturer. There have been several incidents on separate ventilators. Faulty vents are removed from patients and taken to biomed until the problem is addressed by the manufacturer. We cannot take our entire fleet of Evita XL ventilators out of service -- unless anyone has a spare million bucks to donate for new vents or wants to volunteer to manually bag all ventilated icu patients for the foreseeable future.

The manufacturer (Draeger) has given a multitude of different reasons. After each of the reasons given (and actions taken), over a long period of time (>12 months), the problem has reoccured every single time. Sometimes in the same vents, sometimes in different ones.

The problem is not that the hospital or biomed department is unconcerned. The problem is that Draeger is not serious about addressing the problem. There are enough adverse event reports on the FDA website to show that we are not the only hospital where this exact type of problem has happened. But the manufacturer does not appear to care - they appear to think they have done enough to help us, and the whole problem is our fault, so it's turned into an us vs them situation.

I would have expected a little bit more from a company like Draeger. Unfortunately, their service philosophy is second rate. It seems you either take out a service contract with them and pay ridiculous amounts of money for bad service, or you do in-house ventilator service and pay for Draeger to repair when necessary - and still get bad service (and pay ridiculous amounts of money for each repair).

This problem does appear to be isolated to the Evita XL ventilators, but we don't have much in the way of other Draeger equipment. Except for Oxylog's, and they are very good transport ventilators.

jasper_x

Jasper....I was wondering if your problems got resolved. Guess not huh??

That is a problem.....and I can understand that your facility is over a barrel so to speak.....but all it takes is one sentinal event because of those vents as you are very much aware. Keep us posted....hopefully your facility will find some way to resolve this problem....

I guess I have another point of view, since I work for a device company :) It happens occasionally that something occurs in the field which cannot be reproduced back in the lab by the technicians. In that case, it is documented, to be followed up if/when it happens again. I checked the FDA website and noted that some of the problems seem to have been attributed to ESD problems.

I guess you have done all you can do, and as long as everyone is aware to watch for it, what else can you do..?

Jasper X: we are having similar issues.

Hi Sussanna,

Can you or Mike email me? Address is "rwspam at internode.on.net".

Thanks

holy crap!! that's scary!