Field Safety Notice Arjo Sara Plus Lift Risk of Ignition FER14008 and FER14148 (ICN 1634)
Important Customer Notice Field Safety Notice
- Arjo has issued a Field Safety Notice following the discovery that internal damage of the affected HMX1350-1 PCB may lead to overheating of the part and excessive heat emission which could potentially damage the PCB cover or, in the worst case, cause its ignition.
- The technical evaluation of the failure showed that the likelihood of the issue occurrence is limited and dependent on multiple factors. Nevertheless, Arjo is taking this issue seriously as customer satisfaction and safety are essential and have decided to undertake a corrective action to eliminate the identified failure.
- Prior to this, Arjo had received two reports of Sara Plus lift ignition occurring with no report of any health consequences to either patients or caregivers due to the failure mode.
- Two of the affected products are available from NHS Supply Chain via the eDirect route:
|Supplier Code/ MPC
|Sara Plus standing aid
|Sara Plus standing aid electric with scale
- Ensure that all caregivers and users of the Sara Plus floor lift(s) at your facility are made aware of this Field Safety Notice (FSN) and precautionary measures detailed in the Field Safety Notice are followed until the device correction is made.
- The manufacturer identified factors contributing to PCB damage. Several precautionary measures to reduce the potential for damage are recommended until the field action can be completed. These are detailed in the FSN. Please follow all of them until your Sara Plus floor lift is corrected by Arjo.
- Complete and sign the enclosed Customer Response Form, found on page four of the notice, (see our Downloads ▼ section) and return this form to firstname.lastname@example.org.
- Arjo will then schedule the repair of your devices free of charge with the named contact from the customer response form.
- Note: if your facility has sold or moved the Sara Plus lifts, please include the new facility’s information in the Customer Response Form.
If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.