BiPAP A40 affecting Detachable Battery Module

Customer Information Letter
Philips Healthcare
2017-10-A
-1/4-
BiPAP A40 affecting Detachable Battery Module
Incorrect Side Panel
Dear Valued Customer,
Philips Respironics has identified an issue where a non-conforming part (side panel) was utilized on the BiPAP
A40 that affects the mechanical connection between the BiPAP A40 and the Detachable Battery Module (part
number 109677). The issue results in the inability to connect the BiPAP A40 device to the Detachable Battery
Module during setup before putting the ventilator into operation on a user; therefore, there is no safety risk to
the patient. The impacted BiPAP A40 units continue to work properly in configurations without the Detachable
Battery Module.
Enclosed is a list of serial numbers of the potentially impacted devices and instructions on how to inspect for
the non-conforming side panel.
1. Complete the inspection of the devices for the potentially faulty side panel per the inspection
instructions on pages 3 and 4 of this document.
2. Complete only one (1) Business Reply Form (BRF) and list the total quantity inspected, the
quantity of correct devices, and the quantity of incorrect devices.
3. Contact your local Customer Service who will provide direction on how to return your device(s)
for any confirmed faulty side panel replacement.
4. Return completed BRF to Philips via fax or email within 15 business days.
Please note that this action is being conducted voluntarily, in accordance with all regulatory requirements. This
action requires a response from you. Philips Respironics sincerely apologizes for any inconveniences caused
to you and your patients by this issue.
Please contact Philips Respironics Customer Service by phone for assistance
Sincerely,
Philips Respironics
© KONINKLIJKE PHILIPS ELECTRONICS N.V. 2008
All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means,
electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.
Form: 3561
version 0
Customer Information Letter
Philips Healthcare
2017-10-A
-2/4-
BiPAP A40 affecting Detachable Battery Module
Incorrect Side Panel
AFFECTED PRODUCTS
1076493
1076538
1078226
1101899
1111169
1111170
1111172
1111173
1111174
1111175
1111177
1116156
BR1111169
CN1111169
R1076495
R1111169
R1111177
1096770
PROBLEM
DESCRIPTION
A non-conforming part was utilized on the BiPAP A40 that affects the mechanical
connection between the BiPAP A40 and the Detachable Battery Module
HOW TO IDENTIFY
AFFECTED PRODUCTS
Instructions are enclosed for how to detect the non-conforming part and a list of
potentially affected serial numbers is included with this communication. For any
questions, please contact Philips Respironics Customer Service by phone for
assistance
ACTIONS PLANNED BY
PHILIPS
Philips will coordinate replacement of the non-conforming side panel for all
affected equipment identified in the returned Business Reply Form. Philips will
issue a no charge order to replace the affected device side panel.
FURTHER
INFORMATION AND
SUPPORT
If you need any further information or support concerning this issue, please contact
Philips Respironics Customer Service by phone for assistance
BiPAP A40, International
BiPAP A40, France
BiPAP A40, Germany
RP-BiPAP A40 Side Panel
BiPAP A40, International
BiPAP A40, Intl, Private Label
BiPAP A40, Australia, Core Pkg
BiPAP A40, Canada
BiPAP A40 Canada, Heated Tube Core Pkg
BiPAP A40, France
BiPAP A40 System Silver, JP
BiPAP A40, Silver Series
BiPAP A40, Brazil
BiPAP A40, China
BiPAP A40, Japan
BiPAP A40, International-Rental
BiPAP A40 System Silver, JP
Detachable Battery Module, USA/INTL
© KONINKLIJKE PHILIPS ELECTRONICS N.V. 2008
All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means,
electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.
Form: 3561
version 0
Customer Information Letter
Philips Healthcare
2017-10-A
-3/4-
BiPAP A40 affecting Detachable Battery Module
Incorrect Side Panel
1. Remove the Left Side Beauty Cover. Gently depress the tab securing the Left Side Beauty Cover in
place. A small flat head screwdriver may be used to aid in depressing the tab if needed.
2. Inspect the slots in the Left Side Panel for the correct orientation.
3. If inspection confirms both slots are in the correct orientation with the widest portion towards the TOP
of the device, no return is required. Refer to Figure A.
Figure A
Acceptable: Wide part of slot towards the top
© KONINKLIJKE PHILIPS ELECTRONICS N.V. 2008
All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means,
electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.
Form: 3561
version 0
Customer Information Letter
Philips Healthcare
2017-10-A
-4/4-
BiPAP A40 affecting Detachable Battery Module
Incorrect Side Panel
4. If inspection confirms either of the slots are in the incorrect orientation with the widest portion towards
the BOTTOM of the device, return is required for replacement of the Left Side Panel. Refer to Figure
B.
Figure B
Non-acceptable: Wide part of slot towards the bottom
© KONINKLIJKE PHILIPS ELECTRONICS N.V. 2008
All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means,
electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.
Form: 3561
version 0
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