Field Safety Notice Masimo Rad-57 with Select Red SpO2 SET® Direct Connect Sensors (ICN 3491)

NHSSC: 60

Alert:

• Masimo has issued a Field Safety Notice to inform customers of the potential incompatibility of specific combinations of certain Rad-57 used with select SpO2 SET direct connector sensors following customer complaints.
• Masimo received reports that Rad-57 displayed an error/fault message to replace the sensor (“RPL SEN”) or replace the cable (“RPL CBL”) when certain SpO2 SET sensors were directly connected to the Rad-57. This error/fault message prevents the use of the direct-connect sensors with the Rad-57.
• Masimo advises its investigation identified a potential incompatibility error which can occur in the connection between the specific s SpO2 SET direct-connect sensors (P/N 2053, 2054, 2256, 2257, 2643, and 2644) and the Rad-57.
• Masimo advises its investigations revealed incompatibility but no risk to health. It has received no reports of injuries or adverse events associated with Rad-57, and that there is no risk of inaccurate monitoring or interruption of active monitoring, as the devices incompatibility will prevent the monitoring under these conditions.

Products Affected:

• Two products are affected.
• The two products affected are available via NHS Supply Chain:

• Please note FBC85676 may not be visible in our catalogue upon release of this ICN. We are working on fixing the issue.

Next Steps:

• Read and follow the full instructions in the Field Action Notice and share with all users of the affected products.
• Assess your specific Rad-57 device and confirm the compatibility of each SpO2 SET direct-connect sensors (i.e., P/N 2053,2054, 2256, 2257, 2643, 2644) before putting any of them into service.
• Always pay attention to Rad-57 alerts and alarms displayed and post this customer notice as a constant reminder to confirm compatibility of Rad-57 with SpO2 SET direct-connect sensors for those using the devices.
• Complete Attachment 1, page 3 of the notice and email to: CustomerNotice@masimo.com
• If you confirm the incompatibility, Masimo will provide a replacement compatible patient cable and sensor combination. For additional questions or information, please contact your local Masimo Technical Services.
• Masimo advises this notice has already been sent to potentially affected customers.
• If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall, we may need to provide manufacturers, UK responsible Persons, and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.