Source: Medicines & Healthcare products & Regulatory Agency (MHRA)
On the 20th of February 2019, MHRA issued a medical device alert for the professional use monitor/defibrillator: LIFEPAK 15 manufactured by Stryker. The alert is in regards to the risk of device failure during patient treatment and possible failure to deliver therapy. There is a potential for a lock-up condition where the device becomes non-responsive after a defibrillation shock has been delivered. Specific serial numbers are affected.
All medical, nursing and technical staff involved in the use and maintenance of these devices need to immediately take action. Identify affected devices – see the manufacturer’s Field Safety Notice.
- Ensure alternative devices are available or request a loan device from Stryker. If no alternatives are available, perform a local risk assessment.
- Follow actions recommended in the manufacturer’s Field Safety Notice
- Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
Deadline for actions
Actions must be completed by the 6th March, 2019
Remember: If your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.