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

Model Number JAY FUSION

Device Problem Misassembly by Users (3133)

Patient Problems Pressure Sores (2326); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/22/2022

Event Type  Injury  

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.Jay fusion cushion owner's manual, rev f, page 3 states: "warning! do not install this equipment without first reading and understanding the manual.If you are unable to understand the warnings, cautions, and instructions, contact a qualified clinician or supplier - otherwise injury or damage may occur." jay fusion cushion owner's manual, rev f, page 3 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 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 end user reports that when he ordered the jay fusion, the dealer dropped the cushion off with him but did not set it up.This led to the end user setting up the cushion himself.Mr.(b)(6) stated that he may have misinterpreted the instructions when setting up the cushion for his current wheelchair (which is not a sunrise medical product).As stated in the owner's manual, it is important to read and understand the owner's manual before installing equipment to prevent potential injury or damage.The most probable root cause for the alleged injuries is lack of product knowledge or misunderstanding user instructions.He has since had the dealer come to his residence to set the cushion up properly.The end user stated that he believed the cushion just did not work for him specifically.The end user reports that his jay fusion cushion as potentially improperly installed by him has allegedly led to a pressure sore, back/spine pain, and diminished blood flow in both legs.The reported pressure sore is located on his bottom near where the leg connects.The sore allegedly started as an abrasion, became a blister, and then popped.According to the owner's manual, if an end user's skin develops redness, they should discontinue use of the cushion immediately.The end user is reportedly still using the jay cushion but was recommended to stop usage to prevent further pain or injury.The end user reports the wound is closing and healing.Mr.(b)(6) already has a wound specialist that would come once a week for a different pressure wound that is unrelated to the one on his bottom.The additional pressure sore has required stepped up visits from the wound specialist to 3 times a week.The end user reports that sitting on the cushion as installed has allegedly led to severe, continuous back/spine pain.There was no information if treatment is being provided to manage that reported pain.Mr.(b)(6) went to get an ultrasound done and found that he has a blood clot (dvt) in his post back tibia and diminished blood flow in both legs.The end user attributes these findings to use of the jay fusion cushion.He stated that he was working with a new dealer and has ordered a new chair and cushion that will arrive mid-january.Conclusion: although the end user indicated possible product misuse through incorrect installation, due to the allegation of serious injuries (severe pain, restriction of blood flow to legs) and a pressure sore developing that requires medical intervention (increased home visits from a wound care specialist), this mdr is being filed.

Event Description

The end user (b)(6) reports that his jay fusion cushion has allegedly led to a pressure sore, back/spine pain, and diminished blood flow in both legs.Mr.(b)(6) states that he may have misunderstood the instructions when setting up the cushion for his wheelchair.He is receiving stepped up wound care from a wound care specialist and visits with his primary care physician.The end user is still currently using the jay cushion but was recommended to stop usage to prevent further pain or injury.

• 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: 16038989
• MDR Text Key: 306039247
• Report Number: 9616084-2022-00022
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY FUSION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 154 KG