Medical device manufacturer, Arjo, has issued a medical device safety alert concerning its Minstrel floor lift [Model Number: HMA00XX-XX; Manufacturing Date: 1 Jan 2008 to 23 Mar 2010].
The manufacturer has received a small number of incidents from the market claiming the spreader bar detachment when the device was being used. The investigation confirmed that the failure can occur on Minstrel lifts models HMA00XX-XX (without a scale), equipped with the second generation of spreader bar. All Minstrel passive lifts currently manufactured (outside of the above serial numbers) are free of this issue. Minstrel lifts (scale and non-scale) manufactured after 23 March 2010 have an improved design of the spreader bar in which the articulated joint is used, this allows free movement around all 3-axis. In the current design, there are no unfavorable stresses which could be a source of fatigue breakage.
If the spreader bar detaches from the lifting arm, the resident may fall to the floor which may lead to major trauma or head injury. From the manufacturer's investigation which includes evaluation of worst-case scenarios it was concluded that there is a remote chance that the problem may occur.
Customers are asked to verify the version of the spreader bar the lifts are equipped with as stated:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Nov 2018