Source: Medicines & Healthcare products Regulatory Agency (MHRA)
Summary
Manufactured by Philips, the professional use defibrillator/monitor: all HeartStart XL+ (Model number 861290) poses a risk of failure to deliver therapy due to hardware or software issues (described in two separate FSNs). The device may fail to start, unexpectedly restart or deliver defibrillation therapy at the wrong energy level.
The potential problems include:
- failure of the therapy selector switch;
- defect in the memory management software;
- malfunction of the System On Module (SOM) installed on the processor printed circuit assembly (PCA).
Action
- Identify affected devices in your organisation.
- Ensure that:
- staff are aware of the recommended actions in the manufacturer’s two (2) Field Safety Notices issued 30 October 2019 and 31 October 2019;
- if possible, you have ready access to a backup defibrillator until the corrective actions have been undertaken;
- you have systems in place to arrange for the upgrades to be implemented.
- Report suspected or actual 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.
Action by
All medical, nursing and technical staff involved in the use and maintenance of these devices.
Deadlines for actions
Actions underway: 11 February 2020
Actions complete: 25 February 2020
Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for communication from MHRA.