Evaluation of the returned canopy found an open slider in a patient access area, which could allow the unintentional patient escape.In addition, there was a broken pull tab on the left side window.If the zipper slider body is bent open (i.E., the mouth is wider than manufacturing specification) it can prevent the slider from properly engaging the zipper teeth.In areas where the slider engages the teeth, the zipper is secure and cannot be opened.However, if the teeth do not engage it can potentially leave an unsecured area.Applying pressure directly to the unsecured area will reveal the breach , which is why the user manual advises caregivers to apply direct pressure along the entire length of the zipper.Posey beds are multi-use, serviceable items.As such, it is anticipated that the units may occasionally require repair, and as part of standard care the beds should be inspected prior to use.If damage is noted during these routine bed inspections, the unit should not be put into use with a patient and should be returned to posey for servicing.The instructions for use (ifu) state "never use the bed if a zipper slider is bent open or damaged, or if the zipper cannot be zipped completely closed.Remove the patient from the damaged bed and exchange for a posey bed in good working condition.Return the damaged posey bed for repair." service issues are trended and reviewed by management on a monthly basis.As part of this monthly review, trends and excursions above control limits will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time.(b)(4).
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