Health Canada — Medical Devices · Canada · 2022-07-11 · Type II
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Reported risk: The Pro+ Mattress with Advanced Microclimate® Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned. The Pro+ hospital bed surface is a mattress used with various Hillrom hospital beds such as Centrella, Versa care, Advanta, Careassist and Hillrom900 beds. A total of 139 complaints from one customer were received for Centrella bed and mattress issues with Low Air Loss (LAL) errors on the mcm display system from 1 Jan 2019 (earliest distribution date) through 1 March 2022. Initially complaints were raised against the beds, however investigation determined the issue was with the Pro+ Mattress blower system. On 9 March 2022, during complaint investigation, service technicians troubleshooted the issue by reconnecting the system to fix the alarm and error. Log file review later identified several errors in the display which confirmed that the troubleshooting (reconnection of the systems) did not solve the issue. The engineering team determined that the error messages were caused by the blower of the mattress with Low Air Loss (LAL). The impact of this failure mode can cause a reduction in the microclimate management performance of the Pro+, which could result in an increased risk to skin and result in potential pressure injury. Microclimate management is used to reduce skin temperature and moisture of patient skin. No adverse patient experiences have been reported. Recall start date: July 1, 2022
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