Q: Why are you doing this recall?
ResMed announced a voluntary recall program for certain ranges 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 recall program 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 repair, or if necessary replace, your device.
Q:How do I know if my device is part of the recall program?
In order to determine whether your S8 CPAP device requires repair you will need to check both the part number and the serial number. Both of these numbers are located on the bottom of the device.
The recall includes the following serial number ranges for all S8 models:
Q: Are patients at risk?
Patients may continue to use their S8 CPAP device affected by this recall program until they receive their repaired CPAP device. 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 using supplemental oxygen with an affected device. If you are currently using supplemental oxygen, please immediately contact your physician to discuss whether to discontinue use of supplemental oxygen or discontinue using the device until a repair, or if necessary replacement is received. In any event, if you are using supplemental oxygen, please immediately contact your equipment provider for a replacement 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 will only be repaired (or replaced, if necessary) 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 part number and 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 in the illustration below.
Q:How do patients have their device repaired?
Patients will be contacted by their CPAP supplier to arrange repair or if necessary replacement, of their S8 CPAP device. To begin this 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, please contact your device supplier.
Q:How will ResMed be coordinating the recall program?
ResMed will send device suppliers a list of the serial number ranges of the affected devices. Instructions for the recall program will then be sent to patients.
Q:Who can I call if I have additional questions?
Please call your CPAP device supplier, or ResMed’s India office on (91) 11 2645 3592, or ResMed’s distribution partner (Respicure Medsys Pvt Ltd) on (91) 11 4160 5180.