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

Model Number JAY FUSION CUSHION

Device Problem Stretched (1601)

Patient Problem Pressure Sores (2326)

Event Date 05/09/2023

Event Type  Injury  

Event Description

Dealer reports that the air insert seemed to be a different material and the incontinent cover is staying loose.The two factors combined allegedly led to sores developing on the end user's skin.Pictures of the sores were provided by the dealer.There was limited information provided on the incident and injury itself.

Manufacturer Narrative

Background information: the age of the cushion at the time of the complaint was 4 months.The expected lifetime of a wheelchair cushion is 2 years.In reviewing the product and complaint history, there is no evidence of previous issues with the incontinent cover or cushion material.Jay fusion cushion owner's manual, page 6, rev.F states: "check the cover for tears and excessive wear and replace if ripped, torn, or otherwise not fully functional.Inspect the fluid pad for punctures or any other abnormalities." discussion: in reviewing the complaint, the dealer reports that the air insert seemed to be a different material and the incontinent cover is staying loose.The two factors combined allegedly led to pinches on the end user skin and reportedly sores developing.There was limited information provided on the incident and injury itself.The material change claim made by the dealer was investigated and it was determined it was not likely to have been changed or contributed to the looseness of the cushion cover.The most probable cause of the alleged pressure sores would be loose fabric in the well area of the cushion from an oversized (loose) incontinent cover.The loosening of the fabric could lead to rubbing and pinching of the skin in the pressure relieving well area where the end user is seated.There are a few potential failure modes that could link to the loosening of the material.One potential cause could be during the manufacturing process, the cover was not produced to the product specification.Another potential cause of the loosening of the cover fabric could be overstretching of the fabric by the user.Finally, the velcro on the back of the cover could have slippage, leading to displacement of the user and movement of the fabric.According to the jay fusion cushion's owner's manual, any cover for the jay cushion should be checked for any abnormalities that may cause the cushion to not be fully functional and should be replaced if any faults are found during inspection.Additional pictures of the cover itself were requested but the dealer reports the end user is non-cooperative.A request for the return of the cushion along with the cover was made so further evaluation could be conducted, but that yielded no response.Pictures of the sores were provided by the dealer.There is no information on where the pressure sores were located on the end user.Upon review of the pictures by a sunrise medical clinical team member, it was determined that the sores may potentially be stage 3 pressure sores based on their appearance.There has been no information provided by the dealer that describes the diagnosis or treatment of the alleged pressure sores.Conclusion: in conclusion, there is no clear indication of a product malfunction and multiple attempts to contact the end user/dealer for further details on the incident have not yielded any response.While there is limited information on the incident and the reported injuries sustained, due to the allegations of a potential serious injury, this mdr is being filed.The investigation into the matter is ongoing.Upon receiving any additional relevant information from this case, a supplemental report will be filed.

• 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: 17131891
• MDR Text Key: 317207119
• Report Number: 9616084-2023-00035
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY FUSION CUSHION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 78 KG