Affected serial numbers from US00100100 to US00565942 inclusive.
The Philips HeartStart MRx Monitor/Defibrillator may fail to deliver defibrillation therapy in either “Manual Defib”, “AED” or “Sync Cardioversion” mode.
If this occurs, the MRx will simultaneously display the following:
Flat line ECG.
“Device error. Service required” message.
“Shock Equip Malfunction” INOP.
Red “X” in the RFU indicator.
If the problem occurs it can impact either cardioversion or defibrillation therapy within the specified modes. Pacing is not affected.
Identify affected devices.
staff are aware of the recommended actions in the FSN (43Kb);
you have ready access to an alternative defibrillator until the software upgrade has been undertaken;
Philips contact you to arrange installation of the software upgrade.
All medical, nursing and technical staff involved in the use and maintenance of these devices.
This MDA has been sent to:
Care Quality Commission (CQC) (headquarters) for information
HSC trusts in Northern Ireland (chief executives)
Local authorities in Scotland (equipment coordinators)
NHS boards and trusts in Wales (chief executives)
NHS boards in Scotland (equipment coordinators)
NHS England area teams for information
NHS trusts in England (chief executives)
Please bring this notice to the attention of relevant employees in your establishment.
Below is a suggested list of recipients.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
All clinical departments
All clinical staff
Ambulance services directors
Biomedical engineering staff
Clinical governance leads
Health and safety managers
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
Hospitals in the independent sector
Independent treatment centres
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: firstname.lastname@example.org and requesting this facility.
Philips Customer Care Service Centre
Tel: 0870 532 9741