Philips Defect Correction
Philips Magnetic Mask Clips
February 2024In consultation with the TGA, Philips has issued an urgent product defect correction notice for patients using masks featuring magnetic clips.
This is part of a global voluntary notification to inform users of specific sleep therapy masks containing such magnetic components of the updated instructions and labelling. The already present warnings have been strengthened and contraindications have been added.
Masks with magnetic clips may continue to be used according to updated instructions and labelling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.The use of masks with magnetic clips is only contraindicated for patients and their household members, caregivers and bed partners who may be in close vicinity to patients using the masks, that have implanted metallic medical devices/metallic objects that may be affected by magnets.
What will Philips do to support affected patients?
Please contact Philips Sleep and Respiratory Care Hotline on 1800 830 517 if you are affected. Philips will be remediating this issue with clips to replace the magnets or a replacement mask directly to affected patients.
20th September 2023
New updated Philips DreamStation Machines are now available.
18th September 2023
New Philips DreamStation Machines will be available soon.
16th May 2023
Tests clear recalled Philips sleep apnoea machines of health risks
9th November 2021
New Philips Machine Replacements are working their way to registered customers.
IF YOU HAVE NOT DONE SO - PLEASE REGISTER YOUR MACHINE NOW.
5th October 2021
Thankfully, some very long awaited positive news!
The process of correcting defected machines has officially begun - last week the ‘The Philips Defect Correction Team’ began calling the first patients to confirm things like address details so that they could be sent their replacement machine from this month. I think the nitty gritty of the process has now been ironed out a bit and I would expect the machine swapping business to begin ramping up over the next weeks.
IF YOU HAVE NOT DONE SO - PLEASE REGISTER YOUR MACHINE NOW.
An auto-generated notification will be buzzed out this week to all patients using the DreamMapper App on their smart phones. It just tells them that there is a defect with their device and directs them to the portal to register for the defect correction.
There are a lot of patients who have registered on the portal for correction, so Philips will probably be swapping out machines from now, all the way to Christmas.
Just as a matter of interest, the general queue or order of corrections has been sorted alpha-numerically by serial number, so quite random! There were of course some patients that have been pushed to the top of the queue, due to physician instructions or acute illness etc.
If your case is urgent, please let Philips know on 1800 009 579
2nd September 2021
It is frustrating that it seems Philips have not communicated anything directly to registered device owners yet, so here is a quick update...
I have been told that Philips have had over 38,000 devices registered in Australia alone, and that the correction of the devices will be handled by a 3rd party company (APCD).
The DreamStations and DS Go's under 5 years old will, most likely, be replaced with a new devices but we don't know any details of the process yet.
When will this happen?
Their first massive batch of replacement DreamStations is due to arrive late September. In theory, this should be nearly enough to correct most of the devices currently registered. The swap out process will take place during end Sept/Oct/Nov 2021.
I know there is a huge global effort underway to solve this issue. Actually we have many of our own machines to be rectified by Philips, but we are waiting patiently at the very back of the queue so end user devices can have their devices replaced first.
2nd August 2021
Australasian Sleep Association Update:
Patient Information
16th July 2021
Australian Therapeutic Goods Administration (TGA):
If you have not already done so, please register your device at:
https://www.philipssrcupdate.expertinquiry.com/?ulang=en
This information is needed so the company can plan the repair/replacement program efficiently.
Some consumers have reported that they are not sure if their registration has been received. When you register you will get a registration number. If you don't receive this number, please re-register your device.
To help reduce this confusion, Philips is now sending a confirmation email with each new registration.
Towards the end of this month, Philips will begin contacting everyone who has registered their device. They will confirm your details and outline the type of correction proposed for your device. This may take some time given the large number of affected people. Depending on the device type and its age, Philips will either provide a new base unit device or replace the foam component.
6th July 2021
Australian Therapeutic Goods Administration (TGA):
The TGA has classified this matter as an 'Product Defect Correction'
Where possible, Philips will replace the sound abatement foam in affected devices. If this is not possible, a replacement device will be provided.
Information for Consumers:
Do not stop using your device without speaking to your physician or care provider. Stopping treatment suddenly could have an immediate and detrimental effect on your health.
If your device is an affected CPAP, Auto CPAP or bi-Level PAP unit:
Please make an appointment with your physician or care provider before making any changes to your prescribed therapy. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options.
Please ensure you follow the recommended cleaning and replacement guidelines in the operating manual for your CPAP machine and accessories.
Register your device:
You need to register your device on the Philips support website: www.philips.com/src-update. This will allow Philips to contact you to organise the corrective actions or a replacement device.
If you have any questions or concerns, contact Philips Electronics Australia Ltd on 1800 009 579. Further information is available at www.philips.com/src-update.
Retailers/Distributors:
Cease all supply and distribution of impacted devices.
Where possible, Philips will replace the affected foam component in impacted devices.
Latest TGA update on this matter:
https://www.tga.gov.au/alert/philips-recall-action-cpap-bi-level-pap-devices-and-mechanical-ventilators
Australian Sleep Association (ASA):
The ASA has issued a media release on this matter;
https://sleep.org.au/Public/News/Articles/July/media-release-philips.aspx
Philips Update:
Philips have advised that patients need to register their devices ASAP so that they can arrange for the devices to be rectified as soon as possible.
DEVICE REGISTRATION:
Online Device Registration: Click Here.
or Phone to register: 1800 009 579 (9am-6pm AEST Mon-Fri)
We recommend that you follow the TGA/ASA/Philips advice and also register your device ASAP to ensure your product can be repaired or replaced as soon as possible.
If you have any questions, we will do our best to assist, or you can call the manufacturer directly on 1800 009 579
As soon as we receive further news, this page will be updated.
