Reminder: Reporting failures of medical devices

Clinical   kit pic

Please ensure that if a medical device fails or a problem develops when using it, you report it via Datix so it can be investigated thoroughly.

To help the medical devices team do this, please could you note the following details in your Datix report:

  • the make, model and Trust equipment ID number or the unit’s serial number
  • quarantine the equipment and clearly label it as faulty and involved in an incident that will be reported via Datix. A faulty equipment label is available through the supplies department using product code S097
  • quarantine the consumables that were being used at the time (e.g. defib pads, ECG dots, IV giving set) and keep them in a sealed plastic bag, clearly identified as potentially faulty and contaminated
  • retain and quarantine the packaging from consumables you used, which allows us to see manufacturer and batch number details
  • record on Datix where the equipment will be held whilst quarantined
  • contact clinical engineering to report the device issue and any further details.

A thorough Datix report will really help determine the problem and ensure steps are taken to minimise the impact of failures; thank you for your help in this area.

Published 22nd April 2015; reshared 4th March, 2016 

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