Etac calls on dealers to inform their customers of potential risk relating to 2-point sling bar and take action
Etac, the manufacturer of the Molift Mover 180/205 mobile hoist and Molift Air ceiling hoist, has issued a Field Safety Corrective Action (FSCA) for the two-point Sling Bars delivered as an option with the devices.
An FSCA is an action taken by a manufacturer to reduce a risk of injury, death or serious deterioration in the state of health associated with the use of a medical device that is already on the market.
Relating to all Molift two-point Sling Bars of all sizes manufactured from May 2013 to October 1st 2018, Etac says it has received several reports claiming that parts of the composite hook of the two-point Sling Bar have unintentionally broken off.
Despite no reports of patient injuries as a result from the incidents, with the device meeting its performance specifications and performing as intended, the investigation by the moving and handling equipment manufacturer revealed the device was not being used appropriately when the incidents occurred.
Although the risk is related to unintended use, Etac says it considers the risk unacceptable and, as a result, amended the user manual instructions to clarify the correct use of these ranges of hoists.
Additionally, the company has upgraded the Sling Bar design, with all new two-point Sling Bars now equipped with metal alloy hooks, replacing the previously used composite hooks and reducing the risk of product failure.
Supplied in the UK by R82 UK, the affected Molift units are not supplied with serial numbers, therefore, Etac is using its sales records to inform its dealers of the field safety notice and, in turn, is calling on dealers to contact their customers from their own sales records to find out which replacement bars are needed.
Dealers are then asked to contact and order the necessary replacement bar by emailing the invoice number, UK reference, item number and quantity required to firstname.lastname@example.org or email@example.com. After receiving the replacement parts, dealers are required to ship out the bars to affected customers.
The replacement of the two-point Sling Bars is intended to be carried out by dealers’ customers at their own premises, with Etac noting that the individual performing the replacement will need general product knowledge and an understanding of the replacement instruction described in the user manual.