Zoll Powerheart G5 AEDs/Error code (EC) 501 - Priority 2 - Warning

Problem or issue?

The HPRA is issuing this Safety Notice to raise awareness of an issue affecting the Powerheart G5 AED, whereby the device may not deliver therapy when needed. 

After performing normally scheduled self-tests, Powerheart G5 AEDs may display Error Code (EC) 501 and be unable to deliver lifesaving therapy while in this state. The issue can be detected during routine inspection.

What is the risk?

If the error code outlined above is not detected, the device will be unable to deliver lifesaving therapy.

Why is the HPRA issuing this safety notice?

The manufacturer, via their local distributor Fleming Medical, has issued a field safety notice (FSN) in relation to this issue however the rate of acknowledgment from users in Ireland to date has been low. The HPRA is issuing this safety notice to raise awareness of the issue and ensure users undertake the actions outlined in the manufacturer’s FSN.  

What advice has the HPRA for users of these devices? 

1. Refer to the accompanying FSN (linked at the bottom of the page) and follow instructions provided by the manufacturer.
2. Ensure your organisation has a system in place for regular monitoring of these devices. 
3. If an error code EC 501 is detected, Zoll advises that the device should be removed from use.
4. Appropriate action should be taken to resolve the issue, as outlined in the accompanying FSN, and replace the device before it is needed in an emergency situation.
5. Store devices within the recommended humidity range.
6. Report any safety issues associated with these devices to the manufacturer and the HPRA.

Contact information

HPRA contact information

• HPRA online report form

• Telephone: +353-1-6764971

Documents

Product images