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

Model Number JAY FUSION CUSHION

Device Problems Use of Incorrect Control/Treatment Settings (1126); Off-Label Use (1494)

Patient Problem Pressure Sores (2326)

Event Date 09/15/2022

Event Type  Injury  

Manufacturer Narrative

Background information: the age of the cushion at the time of the complaint was 1 year, 1 month.The expected lifetime of a wheelchair cushion is 2 years.Jay fusion cushion owner's manual, page 3, rev.F 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 is breaking down.The end user leans to one side during his work routine due to previous pressure sores that are unrelated to the current pressure sores being reported.The end user explains that he has experienced some sliding and the cushion "wadding up".He reports that the cushion is compressed by 2 inches on the right side, but there is no confirmation since the foam base has not been returned to sunrise medical for evaluation yet.The most probable cause would be the end user not following the directions/warnings in the owner's manual and using the cushion incorrectly by leaning to one side and continuing to use it when redness appeared.Prolonged sitting and lack of pressure relief can potentially lead to pressure sores.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.The end user reports they currently have stage 3 or 4 pressure sores on the side where he consistently leans, which, with treatment, seem to be healing.Conclusion: in conclusion, due to the allegation of a serious injury (stage 3 - 4 pressure sores), this mdr is being filed.Upon receiving any additional relevant information from this case, a supplemental report will be filed.

Event Description

The dealer reports that the end user's foam base for their jay fusion cushion is breaking down.The end user leans to one side during his work routine due to previous pressure sores that are unrelated to the current pressure sores being reported.The end user reports they currently have stage 3 or 4 pressure sores.The foam base has not yet been received for evaluation.

• 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); 2842 n business park ave; fresno CA 93727
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 17325982
• MDR Text Key: 319292812
• Report Number: 9616084-2023-00038
• 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: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• 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: 06/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2022
• 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 Outcome(s): Hospitalization; Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 73 KG