TGA Reference no: RC-2021-RN-02194-1
Product name: DS Maref LX9
Serial numbers: 220112944 to 20117954 and 2026322 to 2032792
Due to improved testing methods we have identified that some LX9 pumps have a fault in the programming. In those cases the pressure experienced in the garments is higher than set on the device. The fault does not present in all pumps tested which leads us to believe it is not a universal issue.
However, to uphold the quality and commitment of our service to our customers and ensure your safety, we are planning to exchange all pumps with the software version 2020.11.01. This alert is being communicated following consultation with the TGA.
We have contacted all affected customers via email and hard copy letter. To determine if your pump is affected look on the bottom of the device, you will find a small sticker with the software version details:
If you have not been contacted but have this software version, please call us on AU 1300 726 666 or NZ 0800 725 555.
What do affected users need to do?
Until we exchange your device, you may still use your pump if you are able to effectively monitor the pressure and identify any unusual changes.
You may continue to use the product under these circumstances:
- You have not noticed fluctuation in pressure between inflation cycles or between uses of the product
- You are comfortable that the product is functioning correctly
- You are able to effectively monitor the pressure and identify any unusual changes
If you have any of the following issues we advise you to cease use of your pump immediately and notify us by phoning AU 1300 726 666 or NZ 0800 725 555.
Cease use if:
- You have experienced pressure fluctuation with your device
- You have cardiac failure or cardiac impairments in any stage or severity
- You have respiratory failure or respiratory impairments in any stage or severity
- You have renal failure or renal impairments in any stage or severity
- You have poor or altered sensation to the region that the compression pump sleeve is being applied
- The user has dementia or similar impairments that can influence mental capacity to identify a change in pressure during treatment
- You cannot judge confidently that the pressure set on the device is being delivered in a consistent manner
- You do not feel comfortable in continuing to use the device until it is exchanged
Over the coming weeks we will be exchanging devices with the affected software regardless of whether the fault is detected by users or not. Please call us on the numbers listed above to register for your exchange.