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الإجراء التصحيحي

Users to follow the actions provided in the attachment.

Action update:
Philips Respironics is pursuing two design changes to correct the High Internal O2 Alarm issue:
• A-Series embedded software changes which will prevent erroneous High Internal O2 Alarms over the entirety of the 5-year expected life.
• Supplier driven component changes with a focus on improved sensor design.

Timeline: The design changes described above are currently expected to be fully verified, validated and released for production and service/repair by the end of 2025.

Loaner program: In recognition of the timeline to deploy corrective actions for the High Internal O2 Alarm issue, Philips Respironics is mobilizing a loaner program. In order to support customers and patients who experience a High Internal O2 Alarm that cannot be cleared.

In the event, the customer decide to no longer wait for the repair device then they are able to request to keep the loaner device free of charge. However, the A Series device will no longer be repaired and returned.

Replacement Device: At the discretion of the patient, caregiver or physician, the customer will be provided with an alternative therapy device DreamStation ST/AVAPS depending on availability, and then the A-series device should be returned to Philips Respironics to minimize disruption in therapy.

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