MAUDE Adverse Event Report: POSEY PRODUCTS LLC EUROPEAN POSEY BED 8080; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8080

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned but have not been received in by manufacturing at the time of this report.Therefore, this report is based solely on the information provided by the customer.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provided adequate instructions and warning 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 failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file # (b)(4).No product returned at this time.

Event Description

Customer reported zipper problems with new canopies out of the box.The spiral of the zipper is not closed correctly.If you do not open the zipper gently, the spiral gets damaged and then the complete zipper needs to be replaced.The date the issue was discovered is unknown and no patient incident or injury was reported.

Event Description

Supplemental report needed for additional information.

Manufacturer Narrative

The zippers were returned by the customer and received on july 19, 2019.The zipper appeared to have been used or removed from a canopy as the polyester tape on both sides had broken threads.Upon evaluation, it was found that the teeth (also known as elements) near the insert and box pins at the bottom stop do not engage securely causing the teeth to be crooked all the way to the top stop.This condition would not be obvious to the user and the canopy could be unintentionally put into use.Zipper issues (teeth not engaging or closing all the way) were noted in october of 2018 from the supplier.Issues with zipper was addressed and corrected via a supplier corrective action (scar).There have not been any other complaints related to this issue in devices manufactured after the completion of the scar.At this time, there is no evidence of recent manufacturing non-conformity.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 #(b)(4).

Manufacturer Narrative

Device evaluated by mfr: customer confirmed will not be returning the product.Without the device, the reported issue could not be confirmed and possible causes of the failure could not be determined.Historical review of the complaint database found other complaints similar to what is reported by the customer.Analysis of the returned products found the teeth of the zippers were not engaging.Zipper issues (teeth not engaging or closing all the way) were noted in october of 2018 from the supplier.Issues with zipper was addressed and corrected via a supplier corrective action (scar).There have not been any other complaints related to this issue in devices manufactured after the completion of the scar.At this time, there is no evidence of recent manufacturing non-conformity.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 warrant.Manufacturer reference file #(b)(4).Product will not be returning.

• Brand Name: EUROPEAN POSEY BED 8080
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• MDR Report Key: 8491551
• MDR Text Key: 145505909
• Report Number: 2020362-2019-00068
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8080
• Device Catalogue Number: 8080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 03/13/2019; 07/22/2019
• Supplement Dates FDA Received: 05/03/2019; 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1