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

Model Number JAY FUSION CUSHION

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

Background information: the age of the cushion at the time of the complaint was 1 year and 1 week.The expected lifetime of a wheelchair cushion is 2 years.Jay fusion cushion owner's manual, page 3: "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." jay fusion cushion owner's manual air insert supplement, page 2 states: "warning! under-inflation: do not use an under-inflated cushion.Using a cushion that is under-inflated reduces or eliminates the cushion's benefits, increasing risk to the skin and other soft tissue.If your cushion appears under-inflated or does not appear to be holding air, check to make sure that all valve(s) are closed by turning the inflation valve(s) clockwise.If your cushion is still not holding air, contact your clinical caregiver and/or supplier immediately." jay fusion cushion owner's manual air insert supplement, page 2 states: "warning! over-inflation: do not use an over-inflated cushion.Using an over-inflated cushion will not allow you to sink into the cushion and will reduce or eliminate the cushion's benefits increasing risk to skin and other soft tissue." jay fusion cushion owner's manual air insert supplement, page 5 states: "if a leak occurs: 1.Place your cushion cells down and over-inflate until all four corners touch.2.Immerse the over-inflated cushion in water to locate the leak.3.Once the leak has been located, mark the leak by inserting a toothpick into the hole.4.Allow the cushion to dry thoroughly.5.Remove the toothpick, and clean the area around the hole with the alcohol wipe provided.Let the surface dry.6.Peel the backing from the patch provided, and centering the patch, place it over the hole.7.Press the patch down firmly until a good seal is achieved.8.The cushion is now ready for use.Adjust the cushion for proper inflation following the instructions in this manual." discussion: in reviewing the complaint, the dealer reports that the jay fusion cushion's air bladder is no longer holding air.The end user's caregiver tried to put the air insert in water, as described in the jay fusion owner's manual air insert supplement, to find the leak but no bubbles were found.The caregiver explains that the end user initially complained of soreness on her bottom, leading to the discovery that the cushion would become soft overnight.The care giver reports that he then began to pump up the air bladder more than required to ensure the bladder would hold air for a longer period of time throughout the day.There is no clear indication pointing to why the air insert is losing air and flattening.The jay fusion cushion is within it's expected lifetime.Based on the warnings provided in the jay fusion owner's manual and the air insert supplement, the care giver should have ceased use of the cushion once the pressure sore was discovered.Using an under/over inflated cushion can reduce or eliminate the cushion's benefits, increasing risk to the skin and other soft tissue.The dealer reports that the end user has allegedly experienced a stage two pressure sore that developed reportedly when the air bladder first began to lose air and go flat.The caregiver currently describes the wound as small and open with healthy tissue.The end user reportedly has a history of pressure sores, unrelated to the cushion or this case, so when the pressure sore in question was found, the caregiver was proactive in setting up treatment.The end user receives help with wound dressing from home health nurses that visit multiple times a week along with biweekly appointments with a wound care center in rhode island for treatment.The cushion has not been returned to sunrise medical for evaluation as of this filing.Conclusion: due to the allegation of a pressure sore developing that requires medical intervention (home health nurse visits and appointments with a wound care center), this mdr is being filed.

Event Description

The dealer reports that the air bladder is no longer holding air.The end user's caregiver tried to put the air insert in water to find the leak, but no bubbles were found.The dealer reports that the end user has allegedly sustained a stage two pressure sore that developed reportedly when the air bladder first began to lose air and go flat.The end user receives help with wound dressing from home health nurses that visit along with biweekly appointments with a wound care center for treatment.The cushion has not been returned to sunrise medical for evaluation as of this filing.

• 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: 15653809
• MDR Text Key: 302248716
• Report Number: 9616084-2022-00020
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY FUSION CUSHION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 45 KG