Customer reports a complaint on product # 2792, 2793, 2794, & 2795.Customer states that patients are able to get out of the restraint cuffs.Staff was able to demostrate that the d-ring was able to fit inside itself and release.Staff reported that this can happen when they tighten the restraint and the patient can also release the restraint with their teeth.Lot# 2792 - 1251t055, 2794 - 2228t047, & 2793 - 2083t023 & 2220t109.
|
H3 the product is scheduled to be returned but has not been received in by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.The instructions for use ifu were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.The ifu states before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.Application instructions state pass the end of the limb strap over the top of the cuff and through the two d-rings on the cuff.Bring the strap back over the first ring and through the two d-rings on the cuff.Slide one finger flat between the cuff and limb strap.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file 2023-000294.
|