FSN – Frequently Asked Questions

About the Field Safety Notice

Which affected items does the Field Safety Notice cover?

The Field Safety Notice only affects the pads for the Philips HeartStart HS1 AED (M5066A), namely:

Philips HeartStart HS1 pads for adults – M5071A
Philips HeartStart HS1 pads for infants and children – M5072A

Are the Philips FRx and accessories excluded from this notification?

Yes. The Philips HeartStart FRx AED (861304) and accessories are completely separate from this safety notification.

Does the Field Safety Notice also apply to the battery?

No. There is no possible issue for the Philips HS1/FRx battery.

Information for the responder or AED owner

What should the AED owner do with the HS1 pads?

Nothing. The pads can be used as is. During use, the responder should ensure that most of the pads surface is covered with gel. The pads can be applied to the patient. If the gel begins to separate from the foam/ tin backing while the yellow plastic is being removed, the responder should try to prevent the gel from folding on itself.

The pads can be applied to the patient as usual unless the gel is almost completely released from the backing. If so, it is recommended to install the spare pads if available. The rescue can then be continued. The spoken instructions provide the responder with the necessary actions, regardless of the status of the pads.

Can the AED owner test in advance whether the pads are in good condition?

No. it is important not to open the pads when the pads are not being used on a patient. The pads are protected by a foil seal. This foil seal ensures that the gel on the pads does not dry out. If the package is opened to check the pads, they can no longer be used during an emergency.

How can the responder see that the pads are not good while using the AED?

The gel on the pads comes off (partially) when the foam/ tin backing is removed. The gel may also appear discoloured and/ or melted. For more information and examples, please read the Philips Field Safety Notice and go to page 2.

What should the responder do if during a rescue they see that the pads are not good?

Install the spare pads cartridge, if available. If this is not present? Then the pads that have already been opened must be used. It is important that most of the surface of the pads is covered with gel. These pads can be applied to the patient. The voice prompt, regardless of the pads status, guide the responder through the process.

What spoken instructions should the responder follow?

Below you find the step-by-step guidance during the CPR process as described in the Philips user manual. Share this with your customer when he/ she requires this information.

AED tells you	Possible cause	Recommended action
…to insert a pads cartridge	The pads cartridge has been damaged.	Insert a new pads cartridge.
…to press the pads firmly to the skin …to make sure the pads have been removed from the liner …the pads should not be touching the patient’s clothing.	The pads are not properly applied to the patient.	Make sure that the pads are sticking completely to the patient’s skin.
…to insert new pads cartridge	The pads cartridge has been opened and the pads peeled off the liner, but the pads have not been successfully attached to the patient. There may be a problem with the pads cartridge.	Replace the damaged pads cartridge. Pull up the handle on the cartridge cover, and replace pads on patient with new pads to continue with the rescue.

Are new pads made and supplied?

Philips will introduce new, modified pads in the course of this year. Anyone who has a Philips HS1 AED of 10 years or younger will receive a new set of pads for free from Philips. In this way, Philips provides everyone with an extra set of pads that 100% meet the high quality requirements of Philips.

Procedure

When do I have to fill in the reply form?

This must be completed and send no later than 30 days after receipt of the email.

What happens if I don’t complete the form within 30 days?

Then you will receive a reminder from us by email. If we have not received the reply form within the period set at that time, we will contact you by telephone. If the reply form has not yet reached us, your right to new pads will expire.

What should I do if I don’t get an answer from my customers?

It is important to approach your customers at least 3 times via 2 different methods.

When will we receive more information about the handling of the Field Safety Notice?

A voluntary Field Safety Notice (FSN) has currently been shared. The Field Corrective Order (FCO) will follow at a later date. The exact date is still unknown. The settlement of the FCO will be announced once the Philips procedure has been announced.

What is meant by documenting the implementation of the FSN?

It is important to keep track of which customers you have notified so that when the FCO comes into effect you know which customers to provide with new pads.