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Pro+ mattress

Official notice

11 Jul 2022

MediumHealth Canada

An official Health Canada notice concerns Pro+ mattress. 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 Published 2022-07-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64351

Official notice

2022-07-11

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64351

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Affected products

Product 1

Affected products - Pro+ Mattress, Lot or serial number - Not applicable., Model or catalog number - P7924A03

Product 2

Affected products - Pro+ Mattress, Lot or serial number - Not applicable., Model or catalog number - P7923A04 P7923A03

Product 3

Affected products - Pro+ Mattress, Lot or serial number - Not applicable., Model or catalog number - P7924A01

Product 4

Affected products - Pro+ Mattress, Lot or serial number - Not applicable., Model or catalog number - P3255A01

Product 5

Affected products - Pro+ Mattress, Lot or serial number - Not applicable., Model or catalog number - P7923A01

Product 6

Affected products - Pro+ Mattress, Lot or serial number - Not applicable., Model or catalog number - P3255A02

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Hill-rom, Pro+ Mattress.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64351

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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