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

Model Number	JAY EASY
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	07/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The swedish medical products agency reported to sunrise germany that an incident occurred with an end user and a jay easy cushion.The end user reported that while sitting in his wheelchair on the balcony and smoking a cigarette, he noticed the seat upholstery began to burn.The wheelchair that the end user was using is not a sunrise medical product.The end user allegedly sustained burns on the back of both of his thighs.The jay easy cushion complies with (b)(4) and is flame retardant.The cushion was returned to sunrise medical for evaluation.
Additional Manufacturer Narrative
Background information: the age of the cushion at the time of the complaint is unknown.The expected lifetime of a wheelchair cushion is two years.Jay easy cushion owner's manual, rev.C states: "avoid sharp objects or exposure to excessive heat or open flame." the jay easy cushion complies with (b)(4) and is flame retardant.Discussion: in reviewing the complaint, the swedish medical products agency reported to sunrise germany that an incident occurred with an end user and a jay easy cushion.The end user reported that while sitting in his wheelchair on the balcony and smoking a cigarette, he noticed the seat upholstery began to burn.The lit cigarette then became stuck between the cushion and the seat upholstery in the front right corner.It is unclear how the incident unfolded.The wheelchair and the jay easy cushion ignited on fire.The wheelchair that the end user was using is not a sunrise medical product.The cushion was returned to sunrise medical for evaluation.There is no further information on the incident and how the fire progressed.The end user allegedly sustained burns on the back of both of his thighs.The burns required the end user to need skin grafts.The end user has been hospitalized since the incident.Conclusion: the information in the complaint indicates the most probable cause as user error due to the lit cigarette/flame coming into extended contact with the wheelchair and cushion, leading to the subsequent fire.There is no indication of a product issue.The product in question met all product specifications before release for distribution at the time of shipping to the customer.This device is used for treatment, not diagnosis.Based on the allegation of serious injuries that required medical intervention and hospitalization, this mdr is being filed.

• Brand Name: JAY SEATING CUSHION
• Common Device Name: 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: 17871377
• Report Number: 9616084-2023-00049
• Device Sequence Number: 7028354
• Product Code: IMP
• UDI-Device Identifier: 00016958047158
• UDI-Public: 00016958047158
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: JAY EASY
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Disability
• Patient Sex: Male