Evaluation results.Visual findings observed that the white hook is torn at the box stitch.The d-ring has been pulled excessively as the butt welded joint has come apart creating a gap leading the d-ring to be separated from the foam cuff.The bed connecting strap has multiple creases indicating excessive force was applied.There is no evidence observed of any workmanship issue, and it appears that the product was applied properly.The box stitches joining the foam, wash label, and webbing remained intact and did not fail, but the failures of the product were in the d-ring and white hook.It appears that excessive force was applied by the patient causing the d-ring and white hook to come apart.The reporter at the user facility was contacted directly for more information surrounding the event.It was disclosed that the device was being used with a patient who displayed continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self, which is a contraindication for this device per the product instructions for use (ifu).This user facility has a history of using these devises with the incorrect patient population per the ifu, as well as incorrect application of the device.However, in this case it appears that the device was applied correctly.The company has been in continuous contact with the user facility over the last year to ensure that they have the support needed to prevent any further adverse events occurring at the facility related to the use of our devices.We have communicated our findings that the reported malfunctions are stemming from a failure to follow the product instructions for use, including not being used on the correct patient population and stated our belief that the correction of this misuse is an urgent matter.We have provided them with options of other potential products that would be better suited for use with their patient population, and offered to perform a virtual product review to answer any questions they may have.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.No corrective or preventative actions are necessary at this time.Manufacturer reference file 2021-00064.
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