MAUDE Adverse Event Report: POSEY PRODUCTS LLC FOAM LIMB HOLDER; RESTRAINT, PROTECTIVE

Model Number 2532

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product is not available for return or evaluation.Therefore, this report is based solely on the information provided by the customer.No lot/serial number provided therefore no device history review can be performed.Historical data found complaints of unintentional patient release for the foam limb holder (part 2532).Of those returned, broken clips, excessive force, and/or wear and tear has contributed to the malfunction.Other complaints of straps slipping or loosening could not be confirmed.There have been 3 complaints received for incompatibility of the 2532 limb holders with beds at hca facilities.There have been 5 complaints received from hca for soft limb holders in the past 2 months.3 of these complaints have been for incompatibility issues with their beds.There have been no other complaints related to incompatibility of the soft limb holders with beds from any other customers.This customer has recently transitioned to using posey limb holders.Due to the coronavirus pandemic, posey has not been able to perform in-service training with this customer.An issue internal investigation has been initiated to further investigate and problem solve the issue.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 provide adequate instructions and warnings for the safe and effective use of the device.The issue of straps slipping described in the event description is a known issue and has been addressed via the change control process.An internal issue review has been launched to investigate the compatibility issues with beds at hca facilities.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).Device is unavailable for return.

Event Description

Sales rep received information on original reported on 10/12/20.Rep reported i have visited the facility in regards to the incident with the 2532.It does not appear to be a buckle slippage issue to me from conversations.Looking at the restraint on the beds on the floor and speaking with staff, the patient was able to slide down in the bed to hit the quick release buckle that connects the 2 straps together.This is primarily due to the location of the non-movable place of the bed in correlation to the patients position in the bed.The connection strap is so long in relation to where it connects to the bed, patients can reach.There are still concerns with the restraint slipping.(b)(6) had a couple of nurses that have worked at other facilities say they slip and had to tie them at the buckle previously.The product did not break or malfunction, the patient was able to reach the buckle and self release, resulting in a caregiver getting injured.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 10804853
• MDR Text Key: 215289773
• Report Number: 2020362-2020-00125
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/09/2020

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: 2532
• Device Catalogue Number: 2532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1