AIRVO and myAIRVO 2 User Instructions Update Feb 2017

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For product you may have distributed:

Step 1:

Please review your sales records and identify if any affected products have been

distributed to your customers. Complete Section B ‘Notification to Customers’ on the

‘Response Form’ and return it to your FPH representative [insert contact name].

Step 2:

If the affected products have not been distributed, please skip steps 2 - 7.

If you have distributed affected products to your customers, then create a list of affected

customers using the ‘Customer Tracking Sheet’ provided in the email. Identify if each

customer is a distributor, retailer, or hospital.

Step 3:

Notify customers immediately via phone or email. Advise them to check if they have any

of the affected products and instruct them to carry out the functionality check above.

Step 4:

Create a ‘Field Safety Notice for Device Modification Letter’ and ‘Response Form’ using

the distributor, retailer, or hospital templates provided in the email and edit the text in red.

Step 5:

Send the ‘Field Safety Notice for Device Modification Letter’ together with a ‘Response

Form’ and the updated User Instructions to all affected customers within five (5) business

days of receiving this letter, using a courier system (mail with track and trace).

Step 6:

Update the following fields on the ‘Customer Tracking Sheet’:

o Date the customers were sent the Letter

o The date each completed response form is received

o Tracking numbers of the letters sent to the customers

Note: All response forms must be kept and sent to your FPH representative [insert contact

name].

Step 7:

Where a customer fails to respond to the ‘Field Safety Notice for Device Modification

Letter’ within 15 business days of initial contact via letter, please follow up a minimum of

three times via courier with a ‘Follow Up Letter’ once every further 15 business days.

Create a ‘Follow Up Letter’ using the template provided in the email. Please document the

date and tracking numbers of the attempts made in the ‘Customer Tracking Sheet’.

TRANSMISSION OF THIS FIELD SAFETY NOTICE:

Please transmit this notice to all those persons within your organisation who need to be aware of it. If

affected products have been distributed to any other customer or organisation, please notify them within

five (5) business days of receipt of this notice.

Please be advised that FPH has notified all appropriate Regulatory Agencies of this field safety notice for

device modification, [including the TGA].

We sincerely apologise for any inconvenience this field safety notice for device modification may cause.

If you have any questions relating to the above actions or have any questions regarding the AIRVO 2 /

myAIRVO 2 speaker function, please contact your FPH representative [insert name] via email at

[email@fphcare.com] or directly at [enter telephone details]. Thank you for your co-operation and

understanding in relation to this matter.

Yours Sincerely,

[Signature]

[Insert sponsor name, position details]

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2. FIRST CONSIGNEE (DISTRIBUTOR/RETAILER/HOSPITAL) FIELD SAFETY NOTICE FOR

DEVICE MODIFICATION RESPONSE FORM

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Fisher & Paykel Healthcare Pty Limited

36-40 New Street

Melbourne, Victoria 3134

Telephone: + 61 3 9879 5022

Facsimile: + 61 3 9879 5232

Website: www.fphcare.com

Field Safety Notice for Device Modification Response Form

AIRVO 2 / myAIRVO 2 User Instruction Update

FPH FSCA Identifier: FA-2016-001

Type of Action: Retail Level

Please complete all of the details below and return this form to your Fisher & Paykel Healthcare

Representative via the details below. A response is required even if you do not have or have not

distributed any Affected Products.

Email:

Fax:

Post:

[insert FPH email address]

[insert FPH fax details]

[insert FPH postal address]

Business Name: ____________________________________________________________

Address:

__________________________________________________________________

__________________________________________________________________

Fax:

_______________________

Phone:

_______________________

E-mail address: ______________________________________________

Section A – Confirmation of Receipt

I have received and read the updated AIRVO 2 / myAIRVO 2 User Instructions. I understand

the additional check is to ensure the speaker is audible prior to each patient use.

Section B - Notification to Customers

I have distributed affected AIRVO 2 / myAIRVO 2 units and I have read and understood my

obligation to notify and send the updated User Instructions to all of my customers who have

affected products.

-

Number of affected customers: ______

-

Number of affected products distributed: _________

Or

I have not distributed any affected products.

Name:

__________________________

Title:

__________________________

Signed:

__________________________

Date:

__________________________

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