EBME Forums Forums Management Medical Equipment Management Managing Med Device involved with patient injury?

Your last line has hit the nail on the head Geoff!

In the event of a reported adverse incident, the device must be removed from use. Take note of any settings and seal the device. Notify the powers that be e.g. MHRA, Health Facilities Scotland etc and follow their advice. No tests should be performed without their permission, otherwise you could be accused of hiding things, no matter how honest you are.

Yes I have been involved with a fatality with a syringe driver.
Before I could complete the form, two CID men turned up under the direction of the procurator fiscal. They confiscated the syringe driver and took it up to IRIC who examined it thoroughly with the manufacturer. I was then asked to submit copies of the service records for that device. Fortunately no problem could be found, either with the device or the records.

So you have to be seen to be whiter than white.