MAUDE Adverse Event Report: POSEY PRODUCTS LLC TRANSFER BELT, QUICK-RELEASE ECONOMY; AID, TRANSFER

Model Number 6537Q

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

Product has been received but evaluation of the device was not completed at the time of this report.This report is based solely on the information provided by the customer.An investigation of similar events found that broken buckles were a result of wear and tear.Of those returned, the product was over 48 months old.There was no serious injury reported in any of the cases.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states "always inspect before each use: check for broken stitches or parts; torn, cut or frayed material; or buckles that are cracked or broken and do not hold securely.Never use soiled or damaged products." 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 #(b)(4).

Event Description

Customer reported while transferring her father from the wheelchair to the bed, the buckle snapped and both the patient and caregiver fell.Neither suffered any injuries.Customer reported having the belt for a few years and did not report the date the incident occurred.

Manufacturer Narrative

Product was received and analyzed.Analysis confirmed the reported issue of the buckle breaking.Two of the prongs on the male component side had broken off and one of the prong was not returned.An inspection of the bottom part of the male component displayed a smooth/rounded surface along the edges.This surface suggested the bottom of the prong broke but the product remained in use for some time before the top part broke.No root cause could be determine during the analysis, but it can be speculated that the break was a result of engaging the female and male components incorrectly and/or wear-and-tear from repeated use.At the time of the complaint, the product had been manufactured over 3 years ago, and it's unlikely the damage was due to a manufacturing non-conformity.Therefore, no corrective or preventative actions are necessary.All complaint are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for the failure mode will be assessed, documented and acted upon as warranted.(b)(4).

Event Description

Supplemental required for additional information.

• Brand Name: TRANSFER BELT, QUICK-RELEASE ECONOMY
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 7208537
• MDR Text Key: 97947710
• Report Number: 2020362-2018-00001
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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: Patient Family Member or Friend
• Device Model Number: 6537Q
• Device Catalogue Number: 6537Q
• Device Lot Number: 4184T107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 75