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On (b)(6) 2015 the following was reported to arjohuntleigh: on (b)(6) 2015 upon the customer visit, arjohuntleigh representative has become aware of the stitching which became loose on the loops of the tailor made sling of 1 particular patient.While further investigating the sling, it became clear that this stitching came loose at several places of the sling.Although the customer indicates no incident happened and no problems with other slings in use were reported.Meanwhile, the customer confirmed that the other sling (same type) for this particular patient is also showing the same signs of abnormal wear on the stitching.On (b)(6) 2015 additional information was received: the slings were normally used on a handi move passive patient lift - not arjohuntleigh lift, but a competitor product that has not been validated by arjohuntleigh.Moreover, it was confirmed that the issue with slings was detected before use and no incident happened (no patient was involved).
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(b)(4).Arjohuntleigh received a complaint where it was indicated that stitching inside of the red, yellow loops of two slings became loose based on the information received.No injuries and no patient involvement was reported.An investigation was carried out into this complaint.When reviewing similar reportable events, we have found a number of cases with similar fault description (loop stitching inside loop failed).The trend observed for reportable complaints with this failure mode is currently considered to be low and stable and slightly increasing.It has been established that the slings were not being used for patient handling at the time of the event.During our investigation two slings were found with red and yellow loops stitching inside loop loose and were found to not have been to specification.Additionally, it was found that the one sling have few stitches at the leg strap loose also.In this place the slings have long series of stitches connecting the loop straps to the main body of the sling.This alone can give an indication that few ripped stitches in this particular place of the sling do not represent a use or safety problem, unless used continuously and/or off-label.(b)(4).It was found that both slings were normally used with a competitor lift - handimove model 1640 passive patient lift.Arjohuntleigh do not approve the use of other manufacturer's products on their equipment.It is not possible for us to guarantee correct, effective and safe use of the combination of our slings with other devices.However, these slings or system were not in use at the time for patient care and it did not cause or contribute to an adverse event, but it is the focus of our report and investigation.Tests carried out during the development of the sling, and in current production on every sling manufactured, would indicate the stitching of the loops meets the oem specification.A proper inspection of the sling should have detected the failure of these slings, especially since attachment points of the red and green loops were broken.Therefore, these slings showing signs of unstitching, should be withdrawn and replaced.After reviewing the complaint it comes forward that the loop breakage occurs in general ways: as the pressure on the sling loop, in the opposite direction of that experienced in normal use which can be caused by the caregiver pulling the loops that way by hand, or, a much higher strain, where the loop/sling becoming caught in an obstruction.This appears to be an indication of the loop being broken due to the application of outside force that causes the break.After this review, we can state the event outcome of the breaking of the loop, is not likely to happen when following the device labeling or the instructions for use (ifu).The sling is not likely to fail during the intended, correct use as described in the ifu, but that a failure can occur during a use error.We find it likely that sling loops broke due to the loop suffering stress that is not likely to be encountered during on-label use.From this evaluation it would appear most likely that the event was caused by the user not following the ifu, due to lack of awareness of the ifu contents.We find this complaint to be reportable to the competent authorities in the abundance of caution.
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