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

Model Number JAY FUSION

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 05/17/2022

Event Type  Injury  

Event Description

End user reports that a replacement air bladder has allegedly caused skin issues/pressure sores to form.The user reports that the skin issues/pressure sores are allegedly developing in the front area where the air bladder starts (the user's lower rear area).The end user also mentions that he allegedly had skin issues/pressure sores with the original air bladder he ordered, leading to him requesting a replacement.The user claims he did not seek out medical attention and the pressure sores allegedly began to heal when he stopped using the cushion, but he also reports he still uses the cushion to this day.

Manufacturer Narrative

Background information: the age of the cushion at the time of the complaint was 1 month.The expected lifetime of a wheelchair cushion is 2 years.Jay fusion cushion owner's manual, page 3, states "caution! 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." pressure sores (open wounds), if left medically untreated, can lead to serious injury.Therefore, out of an abundance of caution, sunrise medical typically considers pressure sores reportable events.Discussion: in reviewing the complaint, the end user reports that a replacement air bladder has allegedly caused skin issues/pressure sores to form.The user reports that the skin issues/pressure sores are allegedly developing in the front area where the air bladder starts (the user's lower rear area).The end user reports that he allegedly had skin discomfort with the original air bladder he ordered, leading to him requesting a replacement.He states that he did not seek medical attention for the alleged skin issues/ pressure sores with either air bladder.The end user alleges that the skin issues/pressure sores had gotten worse when he started using the replacement air bladder and that they began to heal once he stopped using the cushion entirely.There is no indication of the severity of the skin issues/pressure sores.The end user states that where the creases are in the original bladder is where the skin issues/pressure sores are reportedly located.Also, the end user reports the air does not distribute well in the replacement bladder either.Wheelchair seating pads are not perfectly smooth and due to the air distributing throughout the bladder located inside the cushion, there is a reasonable expectation that folds and creases might form.The end user reports he still uses the cushion often, but is in the process of connecting with his dealer and discussing more appropriate cushion options.Given the detail provided, we cannot determine whether the failure mode should be classified as a manufacturing malfunction or as a failure due to end-user misuse.Conclusion: due to previous filings for serious injuries related to what could be similar failure modes if this were a manufacturing malfunction and the related allegation of pressure sores, which could lead to a serious medical condition if any such malfunction were to recur, this mdr is being filed in an abundance of caution.

• 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: 14697991
• MDR Text Key: 294047102
• Report Number: 9616084-2022-00013
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JAY FUSION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• 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
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 68 KG