Philips Australia sets out corrective action relating to urgent quality issue of sleep and respiratory care devices

MedTech News: Philips Australia provided an update on the local corrective action related to the urgent product defect correction authorised by the Therapeutic Goods Administration (TGA) for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices, which addressed identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.

Philips has mobilised the necessary resources across the company to address the component quality issue. The priority is to replace the foam with the new material in all the affected devices either by repairing or replacing with like devices. The company’s efforts include wide-scale, global ramping up of manufacturing, repair, services, and supply chain to support this corrective action.

“During the quarter, demand for ResMed’s Sleep and Respiratory Care devices surged dramatically after our competitor’s recall announcement, putting additional pressure on an already challenging environment for our industry’s supply chain,” said ResMed CEO Mick Farrell recently.

Philips’ repair and replacement plan in Australia is underway, with an initial delivery of replacement DreamStation devices expected to be sent by the manufacturer to Australia in late September. Philips will be contacting registered patients and customers with the relevant information on the next steps to implement this corrective action.

Philips aims to address all affected devices within the scope of this correction but due to the volume of devices and different models that have been affected, we regret it may take some time to repair or replace patients’ devices. Philips will provide further updates on the repair and replacement plan, including for other affected models.

The registration process that Philips has established allows patients, users, or caregivers to look up their device serial number and begin registration if their unit is affected. Registration is the initial important step that patients need to complete to enable the company to organise the repair and/or replacement process for patients.

Philips notes that consumer law rights under the Australian Consumer Law and the New Zealand Consumer Guarantees Act are in addition to any remedy that the company may provide.

Philips is also working on the repair and/or replacement process for New Zealand.

Philips is treating this matter with the highest level of seriousness and regrets the inconvenience this is causing our patients and customers. Philips is absolutely committed to supporting the community of patients who rely on its Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs.