airvo_and_myairvo_2_user_instructions_update_feb_20.pdf
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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
[Date]
Chief Executive Officer
[Facility Address]
Attention: [head of appropriate department e.g. Chief Biomedical Engineer]
Field Safety Notice for Device Modification
AIRVO 2 / myAIRVO 2 User Instruction Update
FPH FSCA Identifier: FA-2016-001
Type of Action: Retail Level Device Modification
AFFECTED PRODUCT DETAILS:
The Fisher & Paykel Healthcare (FPH) AIRVO 2 / myAIRVO 2 humidifiers are designed to treat
spontaneously breathing patients who would benefit from receiving high flow warmed and humidified
respiratory gases. The AIRVO 2 / myAIRVO 2 is not intended for life support.
REASON FOR FIELD SAFETY NOTICE FOR DEVICE MODIFICATION:
FPH has updated the AIRVO 2 / myAIRVO 2 User Instructions to include a check that the speaker is
audible prior to each patient use in order to ensure the speaker is functioning.
AFFECTED PRODUCT MODEL AND SERIAL NUMBERS:
Model Number (REF)
PT101XX
AIRVO 2
myAIRVO 2
PT100XX
Affected Serial Numbers
120521YYYYYY - 160605YYYYYY
ACTIONS BEING TAKEN BY FISHER & PAYKEL HEALTHCARE:
The AIRVO 2 / myAIRVO 2 User Instructions have been updated to include a warning for the user to
check speaker functionality before each patient use. This warning points to the speaker functionality
check contained in all AIRVO 2 / myAIRVO 2 User Instructions.
ACTIONS REQUIRED FROM DISTRIBUTOR/RETAILER/HOSPITAL:
For product in your inventory:
Step 1:
Please perform the speaker functionality check contained in all AIRVO 2 / myAIRVO 2
User Instructions (located in the “Using AIRVO 2” or “Using myAIRVO2” sections): Turn
the unit on and then remove the heated breathing tube. You should see the “check tube”
visual signal and hear the speaker signal.
Step 2:
If either signal is absent, do not use the unit and contact your FPH representative [insert
contact name] to arrange for a replacement device.
Step 3:
Please read the attached updated User Instruction for the affected product. Note the
warnings in section 1, which state ‘Prior to each (patient) use, ensure that the auditory
alarm signal is audible by conducting the alarm system functionality check described in
the Alarms section’.
Step 4:
Complete the attached ‘Response Form’ and return it to your FPH representative.
Step 5:
Please ensure to include the updated User Instructions with each future AIRVO 2 /
myAIRVO 2 sale.
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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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