Model Number 2206 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Product is slated to return to but has not been received by manufacturer at the time of report.This report is based solely on the information provided by the customer.At this time there is no evidence that a manufacturing non-conformity to the reported complaint, and the instructions for use was reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventive 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 future mode will be assessed, documented and acted upon as warranted.(b)(4).No product returned at this time.
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Event Description
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It was reported by the customer that the lock broke off of the restraint.Customer confirmed the patient did not get loose from the restraint and the event did not result in any injury to the patient nor caregiver.The date the issue was discovered is unknown.
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Manufacturer Narrative
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Numerous attempts were made to get the product returned however the customer did not return product for analysis.Historical research of product and like products did not produce any complaint with the same product issue.The instructions for use state "before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch; cracked or 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." manufacturer reference file # (b)(4).
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Event Description
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Supplemental required for additional information.
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Search Alerts/Recalls
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