EBME Forums Forums Thread Like Summary - Servicing LTV 1200 without Training ?

A concerning question I have witnessed within my workplace. Would you allow someone that has some ventilator experience, but no factory training on a LTV 1200 to troubleshoot it. Especially after a alleged incident with the device ? Is there any requirement by the workplace that you should be only factory trained to work on these or troubleshoot these, my understanding that you should be.

thanks for anyone's input on this.

Generally medical device regulations, including those in the UK and Canada, require all incidents involving medical devices to be reported to the manufacturer (or their agent). Therefore, I would start by notifying the manufacturer and see if they want to be involved with the investigation.

If its an incident investigation then as part of the investigation you should simulate a patient and run it. This can be done with the manual or another trained member of clinical staff. To open it up and further investigate i would have someone who is factory trained. Two levels of user really.