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

Model Number 5688

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

The jay cushion involved in this adverse event did not malfunction nor is it reported to be defective.The patient complained of a pressure sore on his bottom.The national institutes of health "journal of medicine and life" (j med life.2010 may 15; 3(2): 149-153) states the following: "the prevalence of pressure sores in acute care units is about 10 %, and in chronic care units this prevalence can be between 3.5 and 50%.More than 60% of the pressure sores occur in elderly patients of over 70 years old and the majority of patients with pressure sores are either paralyzed, elderly or hospitalized.The incidence in pelagic patients is of about 21% for paraplegics and 23% for quadriplegics.[1] they represent the cause of death for 7-8% of paraplegic patients.Pressure sores occur over bony prominences and so, they are most commonly seen at the sacrum (36 to 60%), ischium (6%), trochanters (6%), heel (30%)." therefore, it can be concluded that pressure sores are a common experience in wheelchair users.Although the preexisting condition of the current user is unknown, we do know that the patient is a wheelchair user and most likely has a motor dysfunction that requires regular wheelchair use.The jay air-filled cushion in this use case scenario is designed to stabilize the pelvis, protect skin from the risk of breakdown, and position the body.From the jay cushion owner manual (xt2405, rev d, page 2): "your jay cushion is designed to help reduce pressure.However, no cushion can completely eliminate sitting pressure or prevent pressure sores.The jay cushion is not a substitute for good skin care including, proper diet, cleanliness, and regular pressure relief.Be sure that the velcro® is engaged and able to hold the cushion in place." on the same page of the owner manual: "b.Check sitting pressure often.Your jay cushion was designed for sitting comfort and postural support.Users should inspect their skin daily for redness.The clinical indicator of tissue breakdown is skin redness.If your skin develops redness, discontinue the use of the cushion immediately and see your doctor or therapist." although the jay cushion is designed to reduce pressure points on the wheelchair user's skin, it is not possible to prevent all pressure sores.Therefore, it can be concluded that the development of a pressure sore is not related to any malfunction or poor design of the jay cushion in use in this particular use case scenario.

Event Description

On august 25, 2020, sunrise medical (us) llc received confirmation that an end user, using a jay seating product (manufactured on 04/09/2019), model # 5688, may have caused or contributed to the development of a stage 2 pressure sore defined as: deeper level, below surface - skin is broken, leaves open wound, or appears to have pus-filled blister.Possibly swollen, warm and/or red, may ooze clear fluid.This pressure sore necessitated medical intervention to prevent progression and/or infection.Three treatments were provided (not described) and no further medical treatment was needed.User's height 137 cm, weight (b)(6) kg.It is unknown whether this is a pediatric or adult user.

• Brand Name: JAY
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, CA 93727-1328 ; 5592942374
• MDR Report Key: 10568183
• MDR Text Key: 207983225
• Report Number: 9616084-2020-00006
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5688
• Device Catalogue Number: 5688
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2019
• 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 Weight: 29