PHILIPS BiPAP A40 Pro Ventilator Instruction Manual

: September 10, 2024
: Philips

Table of Contents

PHILIPS BiPAP A40 Pro Ventilator
Product Information
Product Usage Instructions
URGENT MEDICAL DEVICE CORRECTION
Appendix
Instructions on Performing the Hard Reboot
Read User Manual Online (PDF format)
Download This Manual (PDF format)

PHILIPS BiPAP A40 Pro Ventilator

Product Information

Specifications:

Product Name: BiPAP A40 Pro Ventilator
Manufacturer: Philips
Model: A40 Pro
Issue: Alarm Malfunction linked to Oxygen Sensor Inside the Ventilator
Urgent Medical Device Correction Ref#: 2023-CC-SRC-042

Product Usage Instructions

Important Safety Information:
It is crucial to follow the below instructions for the safe and proper use of the BiPAP A40 Pro Ventilator:

Always ensure that supplemental oxygen is connected properly to avoid false alarms.
In case of any alarm indicating high internal oxygen levels, check the oxygen supply connection immediately.
If the device continues to raise the High Internal Oxygen alarm, contact Philips Respironics for assistance.
Patient safety is paramount; always have suitable backup therapies available in case of any device malfunction.

How to Use the BiPAP A40 Pro Ventilator:

Connect the ventilator to a power source using the provided adapter.
Ensure the oxygen supply is connected securely to the ventilator.
Adjust the settings on the ventilator as per the patient’s requirements and prescription.
Monitor the device for any alarms or alerts during operation.
In case of alarm activation, follow the instructions displayed on the screen and take necessary actions.

Frequently Asked Questions (FAQ):

Q: What should I do if the device continuously raises the High Internal Oxygen alarm?
A: If the alarm persists, first check the oxygen supply connection. If properly connected, contact Philips Respironics for further assistance.

Q: Is there a risk of harm associated with the alarm malfunction?
A: Users who are oxygen-dependent should ensure they have backup therapies available to prevent any hazards in case of device malfunction.

URGENT MEDICAL DEVICE CORRECTION
BiPAP A40 Pro Ventilator
Alarm Malfunction linked to Oxygen Sensor Inside the Ventilator

Information for Device Distributors and Healthcare Providers

Philips Respironics has become aware of a potential safety issue with all Bi PAP A40 Pro Ventilators. These ventilators may incorrectly generate a “High Internal Oxygen” alarm. The device will continue to provide therapy while the alarm is addressed. To date, there have been no instances of patient harm or injury reported to Philip Respironics.

As a distributor or healthcare provider managing these devices and patients, you must ensure that users of these devices are appropriately informed of this issue and have adequate support if a device malfunctions. BiPAP A40 Pro devices do not need to be removed from service as a result of this letter. You must support patients and users of these devices with replacement or alternative therapy options if their device malfunctions. Please continue to use the device in accordance with the User Manual. If the alarm occurs, then follow the steps within this letter.

Philips Respironics will continue to provide coverage to any claim of a malfunction raised for the issue disclosed herein. Report all claims of malfunction and adverse event to Philips Respironics by contacting: 1-800-345-6443, prompts 4, 5
This letter must be distributed to all members of your organization responsible for setting up and supervising patients that use these devices. This letter must also be Provided to any organizations to which you have further distributed BiPAP A40 Pro Ventilators

URGENT MEDICAL DEVICE CORRECTION

BiPAP A40 Pro Ventilator
Alarm Malfunction linked to Oxygen Sensor Inside the Ventilator

This document contains important information for the continued safe and proper use of your equipment_

Please review the following information with all members of your staff who need to be aware of the contents of this communication or patients that are using the device.
Please retain this letter for your records.

Philips Respironics has received one thousand eight hundred twenty-eight (1,828) reports of incorrectly generated a “High Internal Oxygen” alarm for all BiPAP A40 Pro Ventilators which is a probability rate of 3.9%. To date, there have been no instances of patient harm or injury reported to Philip Respironics. This URGENT Medical Device Letter is intended to inform you about this issue.

What the problem is and under what circumstances can it occur
The “High Internal Oxygen” alarm is intended to detect oxygen accumulation within the ventilator that may occur while supplemental oxygen is being provided to a patient. Philips Respironics has identified issues in this oxygen’s sensor manufacturing process that can cause the sensor to malfunction,
inaccurately reporting elevated oxygen levels to the device when elevated levels are not present.
When this happens, it can cause the device to incorrectly detect elevated oxygen concentration, even when supplemental oxygen is not connected to the device. The device will continue to provide
therapy while the alarm is addressed (in accordance with the User Manual). This issue can manifest itself in the following forms:
The device continuously raises the “High Internal Oxygen” alarm, while supplemental oxygen is connected.
The device continuously raises the “High Internal Oxygen” alarm, while supplemental oxygen is not connected.
Hazard/harm associated with the issue
If users are oxygen-dependent and they disconnect the oxygen supply without switching to a
supplemental source, they could experience hazards that include hypoxemia. Ventilator and oxygendependent patients are advised to have suitable backup therapies available in the event of any device malfunction.
Affected products and how to identify them
- This issue affects all BiPAP A40 Pro Ventilators
- A list of impacted part numbers is provided with this letter.
- Refer to labeling on the device (as shown below).
  To identify the model, refer to the part number on the bottom of the device with the attached list of impacted part numbers:
Actions that should be taken by the user in order to prevent risks for patients
The User Manual instructs to disconnect the oxygen supply when the “High Internal Oxygen” alarm occurs. This may not clear the alarm if the sensor malfunctions.
- All alarms must be responded to following the instructions provided by the device User Manual.
- Any patient that is dependent on their device should have suitable backup therapies available in the event of a device malfunction. This includes situations where an alarm cannot be cleared.
- Remove the patient from the device and switch to an alternative therapy device if you experience a “High Internal Oxygen” alarm that cannot be cleared.
- Contact your device distributor/healthcare provider if you experience an alarm or malfunction that cannot be resolved following the device User Manual.
  Actions for Physicians:
- Refer to Appendix A: Guidance for physicians/healthcare professionals related to FSN
- Complete the response form attached if this came directly to you from Philips Respironics
  Actions for Patients and Users:
- Follow these steps if “High Internal Oxygen” alarm occurs:
- For facility-based clinicians. if the High Oxygen Alarm occurs. immediately remove the patient from the device and connect them to an alternate source of ventilation.
- For home-based patients. if the High Oxygen Alarm occurs, immediately remove the device and connect to an alternative device, if available. Contact your home care equipment provider for service and/or an alternative device.
- Refer to Appendix B: Guidance for end users/home care providers related to FSN. As an optional action, you may perform a “hard reboot” (forced device restart) that may
  temporarily restore device function. The details and instructions for performing this hard reboot are contained in Appendix C, shown below.
- After a hard reboot is performed, please confirm that the ventilator settings are correct.
  Actions for Distributors/OM Es:
- Identify the customer list where you have distributed this product and notify them immediately.
- Distributors should have customers complete and return the Customer Response form to your organization for your reconciliation purposes within 30 days.
- Complete and return the attached Customer Response Form to Philips Respironics following completion of your reconciliation activities.
Actions planned by Philips Respironics to correct the problem
Philips Respironics is currently investigating this issue and will implement appropriate actions to prevent recurrence.
If you need any further information or support concerning this issue, please contact your local Philips Respironics representative: 1-800-345-6443, prompts 4. 5 or email at respironics.clinical@philips.com.
Philips Respironics regrets any inconveniences caused by this problem.

Sincerely,
Tracie Capozzio
Head of Quality Therapy Platforms

Impacted Devices/Models

A40Pro

Appendix

Guidance for physicians/health care professionals related to FSN 2023-CC- SRC-042

Dear Physician/Healthcare Professional,
Philips recently sent a Field Safety Notice, entitled “BiPAP A40 Pro Ventilator Alarm Malfunction finked to Oxygen Sensor Inside the Ventilator’ to_DME {Durable Medical Equipment) suppliers and medical institutions that have patients who are using these devices. A copy of this Field Safety Notice is included with this letter.

To support physicians/healthcare professionals who manage patients using ventilatory devices in the home setting, Philips is providing additional guidance regarding the continued use of these devices.
Philips is recommending that physicians/healthcare professionals assess whether the patients under their care can tolerate interruptions of therapy to help ensure that they continue to receive the most appropriate therapy.

For Patients/User:
If the High Oxygen Alarm occurs, the patient/user caregiver will have instructions to remove the patient from the device and place them on an alternate device.

If they do not have an alternative device, they can contact their equipment provider or DME for assistance with obtaining an alternative device.

Optional Step: Patients (or lay caregivers) may perform a “hard reboot” after High Oxygen Alarm occurs:
The hard reboot in some cases may temporarily restore therapy to the patient which could allow them to continue to use the device while waiting for an alternate device from their DME or equipment supplier.

Please refer to Appendix C (attached) Instructions on Performing the Hard Reboot.

Appendix B: Guidance for patients/users related to FSN 2023-CC-SRC-042 FSN

Background

The ventilator has an alarm called the “High Internal Oxygen” alarm. The “High Internal Oxygen” alarm is intended to detect oxygen accumulation within the ventilator that may occur while supplemental oxygen is being provided to a patient. Philips Respironics has identified issues in this sensor’s manufacturing process that can cause the sensor to malfunction, inaccurately reporting elevated oxygen levels to the device. When this happens, it can cause the device to incorrectly detect elevated oxygen concentration, even if supplemental oxygen is not connected to the device. The device will continue to provide therapy while the alarm is addressed (accordance with instructions for use). If using supplemental oxygen, please consult physician on next steps

Please share and discuss the attached physician letter (Appendix A) and the FSN (Field Safety Notice) with your physician/health care professional for their awareness and to allow them to make relevant recommendations for your treatment.

What to do if the High Oxygen Alarm Happens:
If this High Oxygen Alarm occurs, immediately remove the ventilator and if required, connect to an alternate source of ventilation. Contact your home care equipment provider or DME (Durable Medical Equipment) for service and assistance.

Optional Step:
You (or someone taking care of you) can perform a “hard reboot” (or restart) on your ventilator which may allow for temporary usage of the device until you can be placed on an alternative ventilator. If reboot is done and alarm comes back, please contact your DME. If no alarm occurs again, the device is fine to use while waiting for replacement device.

Please refer to Appendix C (attached) Instructions on Performing the Hard Reboot.

Instructions on Performing the Hard Reboot

Performing a Hard Reboot

If a High Oxygen alarm occurs, the alarm will sound, and an error will be logged as shown below.

Warning: Immediately remove the patient from the ventilator and if required, connect them to an alternate source of ventilation. Contact your home care equipment provider for service.
Meanwhile, as an option you may follow these steps to try to temporarily restore ventilatory function while waiting for a replacement device and/or professional medical intervention.

Power off the therapy device.
- Wait 30 seconds to restart the device
- Prees, the Start/Stop button( )
- If the ventilator display is operational, the “Power Off’ confirmation screen will appear, as shown below.
- Select the button on the right side, “Yes” to shut off the device and silence the alarm.
- If the High 02 alarm returns after the hard reboot, the alarm cannot be reset, and supplemental oxygen should be removed
- If the High 02 alarm does not return, the device can be used with supplemental oxygen again
Unplug the power cord from the wall or from the device itself.
If applicable, remove the battery from the therapy device.

Detachable Battery Pack

If the detachable battery pack is used, open the battery compartment at top of the detachable battery module accessory.
Lift battery out using release lever on top of the battery (see below).