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

Model Number	JAY FUSION
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On october 24, 2025, the dealer called to report that the air bladder is leaking air, and the dealer thinks it is leaking around the valve.Customer service agent had the dealer do a suds test.Dealer stated the valve was not tight, tightened the valve and there were no bubbles.Dealer states that it is the only place it would leak air.He did not check the seams, not the bladder itself.He added air to determine if it would hold air.Per the dealer, the user states she got the cushion because "she already had bed sores" and now, they are worse.The air started leaking 2 weeks ago.The user went to a wound care center on the previous date and is due to go back in 2 weeks and would be seeing a nurse.User is 5'5, 235 lbs.And born (b)(6).Dealer states he will give it 24 hours to see if the leak has stopped.There were no updates and no further complaints made on this issue, so it can be concluded that the tightening of the valve resolved the issue.
Additional Manufacturer Narrative
Background information: the age of the wheelchair cushion at the time of the complaint was approximately 260 days.Jay fusion cushion owner's manual states: "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 fusion cushion is designed to help reduce pressure.However, no cushion can completely eliminate sitting pressure or prevent pressure sores.The fusion cushion is not a substitute for good skin care including but not limited to; proper diet, cleanliness, and regular pressure reliefs." discussion: in reviewing the complaint, the dealer reports that the end user's foam base for their jay fusion cushion was leaking air.The end user claims to have already had pressure sores prior to ordering this cushion.The most probable cause would be the end user not following the directions/warnings in the owner's manual and using the cushion in a prolonged manner after there were noticeable abnormalities and the malfunction of the valve by not continuously maintaining the intended form or air.The cushion should be inspected to check for abnormalities prior to use.If proper support is not provided, the end user should discontinue using the cushion and immediately contact their sunrise medical supplier.According to the jay fusion cushion owner's manual, any cushion should be tested against the user's skin to ensure skin redness does not occur.If the end user's skin develops redness, they are to discontinue the use of the cushion immediately and see their doctor or therapist.Conclusion: the reported event is most likely a product malfunction.However, the user should have made sure the device was functioning as intended before continued use that could possibly lead to worse pressure sores than she had already previously had.The product in question met all product specifications before release for distribution at the time of shipping to the customer.This device is used for treatment, not diagnosis.The failure mode has been previously reported per 21 cfr 803.50.

• Brand Name: JAY FUSION
• Common Device Name: CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n. business park ave.; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL TECNOLAGIAS S A DE CV; privada misiones no. 110; parque industrial misiones; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: paul barnhart ; 12002 volunteer blvd; mt.juliet, TN 37122
• MDR Report Key: 23650925
• Report Number: 9616084-2025-00089
• Device Sequence Number: 17349649
• Product Code: IMP
• UDI-Device Identifier: 00016958056563
• UDI-Public: (01)00016958056563(10)2262025
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: JAY FUSION
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 107 KG