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

Model Number JAY ZIP

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

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

Event Date 10/02/2023

Event Type  malfunction  

Manufacturer Narrative

Background information: the age of the wheelchair cushion at the time of the complaint was approximately 1 year and 2 months.The expected lifetime of a wheelchair cushion is two years.Jay zip cushion owner's manual, rev a, page 2 states: "warning! prior to prolonged sitting, any cushion should be tried for a few hours at a time while a clinician inspects your skin to ensure that red pressure spots are not developing.You should regularly check for skin redness.The clinical indicator for tissue breakdown is skin redness.If your skin develops redness, discontinue the use of the cushion immediately and see your doctor or therapist.The jay zip cushion is designed to help reduce pressure.However, no cushion can completely eliminate sitting pressure or prevent pressure sores.The jay zip cushion is not a substitute for good skin care including proper diet, cleanliness, and regular pressure relief." jay zip cushion owner's manual, rev a, page 3 states: "easy maintenance & cleaning: monthly cleaning and maintenance may help extend the life of your cushion.During 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." discussion: the most probable cause for "bottoming out" 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.The dealer reports that the cushion is flattening out.The end user's mother reports that she noticed the cushion was flatter than normal.As stated in the jay zip 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 end 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.

Event Description

The dealer reports that the cushion is flattening out.The end user's mother reports that she noticed the cushion was flatter than normal.The dealer has requested a replacement cushion per the warranty f.No user injuries or adverse impact were 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: 18051724
• MDR Text Key: 327145505
• Report Number: 9616084-2023-00065
• Device Sequence Number: 1
• Product Code: IMP
• UDI-Device Identifier: 00016958056594
• UDI-Public: 00016958056594
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JAY ZIP
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2022
• 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 Sex: Female
• Patient Weight: 32 KG