This report is being filed under exemption: e2012070 by arjohuntleigh polska sp.Z o.O.(registration#: (b)(4) on behalf of the importer arjohuntleigh, inc.(ahus) (registration#: (b)(4).On 2018-03-20 arjo was informed about the complaint involving accessory, adjustable handle and strap.The incident took place in (b)(4) france.Following the information provided the adjustable handle broke while a patient was using the accessory to reposition himself.As a result, the patient sustained brow bone injury.Based on the information collected to date, provided problem description and photographic evidence, it has been found that the actual piece that has broken is the belt retractor housing which provides the adjustment of the strap.The defective adjustable lifting handle has the tractability mark showing that it has been manufactured on oct 2007, making the item almost 10,5 years old at the time of the event (march 2018).The accessory was not under arjo service contract.The frequency and scope of the maintenance activities performed on the involved product remains unknown.In order to reduce the risk of patient using the device over its lifetime, the product instruction for use (e.G.746-439 rev.8) informs: "the operational life of the strap and handle is five years when used and maintained in accordance with the manufacturer's instructions.After this time the complete unit should be replaced".Taking into account all the above it appears that this particular failure is the result of prolonged use of the adjustable lifting handle.Although there were no injuries reported, the complaint was decided to be reportable due to adjustable handle breakage.There was no indication of patient's involvement at the time of the malfunction occurrence.The accessory was reported to break and from that perspective the item did not work up to manufacturer's specification.
|