MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC JAY SEATING CUSHION; WHEELCHAIR CUSHION

Model Number JAY LITE

Device Problems Degraded (1153); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2022

Event Type  malfunction  

Manufacturer Narrative

Background information: the age of the cushion at the time of the complaint was approximately 2 months.The expected lifetime of a wheelchair cushion is 2 years.Jay lite positioning cushion owner's manual, rev c, page 3 states: "warning! always avoid exposing your cushion to sharp objects, excessive heat or open flames, and prolonged exposure to environmental conditions like freezing temperatures and/or direct sunlight." jay lite positioning cushion owner's manual, rev c, page 4 states: "easy maintenance & cleaning regular cleaning and maintenance may help extend the life of your cushion.Before, during, and after cleaning, component inspection is recommended.Check the cover for tears and excessive wear and or any other abnormalities.Check the foam base to ensure foam consistency.Check the pelvic loading area to ensure reticulated foam consistency." ufmea jay cushion, risk id 20 states: pressure relieving foam in the pelvic well area collapses due to compression set, excessive wear, or aging resulting in an incorrect or uncomfortable positioning or continuous rubbing.Discussion: the most probable cause for "cushion breakdown" for a foam cushion is degradation, or the foam losing its intended shape when being used by the end user.This may cause the cushion to no longer provide sufficient seating and positioning support necessary for the user's specific needs.As stated in the jay lite positioning cushion owner's manual, the cushion should be inspected to check for abnormalities to the foam consistency.If proper support is not being provided, the user should discontinue using the cushion and immediately contact their sunrise medical supplier.Conclusion: the information in the complaint indicates a reduction of pressure relieving capabilities in the pelvic well area related to deformation of the foam material.The reported event is most likely a product malfunction.The product in question met all product specifications before release for distribution at the time of shipping to the customer.The relationship between the reported event and the device for failing to meet life expectancy is not known.This device is used for treatment, not diagnosis.The failure mode has been previously reported per 21 cfr 803.50.This complaint was re-evaluated during a retrospective review and remediation effort resulting from improvements made to the company's complaint handling and adverse event reporting processes to ensure patient safety and regulatory compliance.This mdr is being filed based on the outcome of that retrospective review.Should additional information become available, sunrise medical will file a supplemental report.

Event Description

It was reported that the patient states the foam base is breaking down and the front right corner is flopping around.This was noticed on (b)(6) 2022.No injuries or adverse impact to the user was reported.

• Brand Name: JAY SEATING CUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 17078605
• MDR Text Key: 316861280
• Report Number: 9616084-2023-00007
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2023

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: Lay User/Patient
• Device Model Number: JAY LITE
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2022
• 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
• Patient Weight: 39 KG