Britannia-Irlanti

Q:Why are you doing this recall?

ResMed announced a voluntary replacement program for certain of its S8 CPAP devices as a precaution against the remote possibility for a short circuit in the devices’ power supply connector.

Q:What happens to the devices?

In rare cases, a short circuit in the power supply printed circuit board inside the device has caused the devices to fail. In seven of those cases, the short circuit caused thermal damage to the outside of the devices, but no significant property damage or patient injuries have been reported.

Q:What action is ResMed taking?

ResMed will implement a product replacement programme as a precaution against the remote possibility of a short circuit in the power supply connector of your device.

ResMed will work with your CPAP supplier to send you a new device

Q:How do I know if my device is part of the replacement program?

In order to determine whether your S8 CPAP device require replacement you will need to check the serial number. This number is located on the bottom of the device.

In Europe, the following Tuotteet are affected:

  • S8 Autoset Spirit
  • S8 Elite
  • S8 Prima
  • S8 Escape

Only those products listed by serial number in this range are affected:

Alkaen Asti
20040285613 20060283743
20060287568 20060294694

Q:Are patients at risk?

Patients may safely continue to use their S8 CPAP device affected by this replacement program until they receive their new CPAP. As with any electrical device, patients should make sure that the device is placed on a hard, clean surface during use. You should also observe the following precautions during use:

  • ResMed does not recommend that you use supplemental oxygen with an affected device. If you are currently using supplemental oxygen, please immediately contact your physician to discuss whether you should discontinue use of supplemental oxygen or discontinue using your device until you receive a replacement. In any event, if you are on supplemental oxygen, please immediately contact your equipment provider for a replacement device.
  • Minimise unplugging or moving of the device.
  • Discontinue use of the device if you experience any signs of electrical failure such as: intermittent power, cracking sounds, sparking, burning smell.

Your device is only included in the replacement program if it is within the serial number ranges shown above.

Q:How do I locate the device’s serial number?

The 11-digit serial number is located on the bottom of the device under the bar code.

To locate the serial number on your S8 CPAP device:

1. Unplug the device at the wall.

2. If you use a humidifier, disconnect it before turning the device over.

3. Turn the device over. The part number and the serial number are found below the barcode as shown i28-05-2007erside.jpg" width="470" height="248" />

Q:How do patients receive their replacement device?

Patients will be contacted by their CPAP supplier to arrange delivery of a replacement S8 CPAP device. To begin the replacement process you will need the serial number located on the bottom of your device.

Q:Should I return my old device or destroy it?

Please do NOT destroy your old CPAP. Instead, it should be returned according to the advice of your CPAP device supplier. If you have any questions please contact your device supplier.

Q:How will ResMed be coordinating the replacement program?

ResMed will send device suppliers a list of the serial number ranges of the affected devices. Instructions for the replacement program will then be sent to patients.

Q:Who can I call if I have additional questions?

Please call your CPAP device supplier.