EBME Forums Forums Management Medical Equipment Management Zoll X-series Advanced - High Failure Rate

Advisory Notification

St John Ambulance (SJA) has encountered a high failure rate 12/40 within the delivery of 40 Zoll X-series Advanced Monitor Defibrillators. This consisted of two batches delivered to the charity in April /May this year.
Affected batches have serial numbers that start:

• AR22D06*****
• AR22E06*****

The failure presents in two ways:

• Device fails to power on (mains/battery) when on/off button depressed
• Device powers on without command (from on/off button) when battery inserted, or mains applied.

SJA are working with Zoll UK, their European QA Manager and Zoll UK are reaching back to manufacturing in the USA.

SJA are pressing for a Field Safety Notice (FSN) to be developed and issued but at this time Zoll state they have insufficient evidence to formulate the FSN.

SJA is taking the action/decision to remove this batch of 40 Defibrillators out of service to ensure maximum patient safety. Our passion for patient safety is such that we believe it is right that we share this information with partners to protect patients.

Zoll have assured us that this is receiving their highest priority investigation and we continue to work with them to provide all they need to investigate.

SJA has raised a yellow card with MHRA. 2022/009/027/501/001 refers.



Chris Last
National Equipment Manager
(Medical Device Safety Officer)
St John Ambulance
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