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

Model Number JAY J2DC CUSHION

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

Patient Problem Pressure Sores (2326)

Event Date 12/21/2023

Event Type  Injury  

Event Description

Dealer reports that the fluid pad developed air bubbles.Per the dealer, the end user's mother stated that there were no air bubbles when the cushion arrived but that they developed after a few days.Dealer provides that the end user has allegedly developed a pressure wound.There was no information provided on characteristics and staging of the wound.Per the dealer, current treatment involves hyperbaric chamber treatment once a week and bandage changes once a day.This device is used for treatment, not diagnosis.

Manufacturer Narrative

Background information: jay j2 deep contour cushion owner's manual rev.D, 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." jay j2 deep contour cushion owner's manual rev.D, page 2 states: "warning! 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." discussion: in reviewing the complaint, the dealer reports that the fluid pad developed air bubbles.According to the end user's mother, there were no air bubbles when the cushion was originally received but developed after a few days.Per the dealer, there were no apparent leaks in the fluid bladder, the end user is not located in a high-altitude area and the end user reportedly stopped using the fluid pad when pressure sores developed and began to use a previous cushion.A dhr review for this product was conducted and no abnormalities, deviations or ncmr's related to the claim were identified in the manufacturing process.The jay2 dc cushion was made to specification.The end user has allegedly developed a pressure wound in the same location that he had a previously healed sore.The pressure wound is on the right side, located close to the ischial.There was no information provided on characteristics and staging of the wound.Per the dealer, current treatment involves hyperbaric chamber treatment once a week, bandage changes once a day and pressure shifts every 10-15 minutes.Conclusion: in conclusion, due to the allegations of a potential serious injury that requires medical intervention (nonspecific pressure injury requiring hyperbaric chamber treatment), this mdr is being filed.

• Brand Name: JAY CUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL TECNOLOGIAS S.A. DE CV; privada misiones no. 110; parque industrial misiones; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727
• MDR Report Key: 18807718
• MDR Text Key: 336619680
• Report Number: 9616084-2024-00004
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY J2DC CUSHION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 109 KG