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

Model Number JAY ION CUSHION

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

Background information: the age of the cushion at the time of the complaint was 1 year and 3 months.The expected lifetime of a wheelchair cushion is 2 years.Jay ion wheelchair cushion owner's manual, page 2, 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 ion cushion is designed to help reduce pressure.However, no cushion can completely eliminate sitting pressure or prevent pressure sores.The jay ion cushion is not a substitute for good skin care including proper diet, cleanliness, and regular pressure relief." ufmea_jay cushion, risk id 28 states: "pressure relieving materials fails to provide necessary resilience.Pressure relieving medium no longer provides sufficient support for client.Client bottoms out on the support surface." discussion: in reviewing the complaint, the end user's physical therapist (pt) (b)(6) reports that the patient's jay ion cushion is "bottoming out." this has allegedly led to the end user experiencing pressure sores on the bottom and scrotal area.A potential root cause is that "bottoming out" occurred due to the foam in the cushion losing its shape in the area underneath the pelvic bones and/or buttocks of the user.The cushion is still within its expected lifetime of 2 years.It was reported that the end user has continued to use the cushion.As stated in the owner's manual for the cushion, if skin breakdown occurs, the end user should discontinue the use of the cushion immediately and contact their doctor/therapist.Due to lack of information, there is no indication that would allow us to determine whether the root cause of this failure is due to a product malfunction during normal use or potential user misuse (end user not performing pressure relief activities or good skin care by direction of medical professionals).The end user is not yet working with a dealer, but mentioned to the pt that they were going to contact a dealer for a replacement cushion.The cushion at issue has not been returned to sunrise medical for evaluation as of this filing.The physical therapist reports that the end user had been sent to the hospital by the wound specialist because the reported condition of the pressure sores surpassed their treatment capabilities.There are limited details in regards to current treatment and severity because the end user moved states and there was no contact information provided.The pt stated that she no longer had any updates since the patient was done with her services.Conclusion: due to the allegation of serious injury, possibly related to a similar potential failure mode of foam breakdowns and the related allegation of pressure sores developing that require medical intervention, this mdr is being filed.

Event Description

The end user's physical therapist (pt) (b)(6) reports that the patient's jay ion cushion is "bottoming out." this has allegedly led to the end user experiencing pressure sores on the bottom and scrotal area.The end user was being seen by a wound specialist and a home health nurse that visited twice a week.The pt reports that the end user had been sent to the hospital by the wound specialist because the reported condition of the pressure sore surpassed their treatment capabilities.There are limited details in regards to treatment and current severity because the end user moved to a different state and there was no contact information provided.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); 2842 n business park ave; fresno CA 93727
• 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: 15594887
• MDR Text Key: 301641250
• Report Number: 9616084-2022-00018
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY ION CUSHION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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): Other; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 79 KG