Health product recall

Pro+ Mattress

Brand(s)
Last updated

Summary

Product
Pro+ Mattress
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products

Lot or serial number

Model or catalog number

Pro+ Mattress

Not applicable.

P7924A03

Pro+ Mattress

Not applicable.

P7923A04
P7923A03

Pro+ Mattress

Not applicable.

P7924A01

Pro+ Mattress

Not applicable.

P3255A01

Pro+ Mattress

Not applicable.

P7923A01

Pro+ Mattress

Not applicable.

P3255A02

Issue

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
 

Additional information

Details
Original published date: 2022-07-13
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

Hill-Rom, Inc.

1069 State Route 46 East, Batesville, Indiana, United States, 47006-9167

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-64351