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

Model Number J2 DC CUSHION

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

Patient Problems Hemorrhage/Bleeding (1888); Pressure Sores (2326)

Event Date 03/29/2023

Event Type  Injury  

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 wheelchair repair technician reports that the "gel sack" in the cushion had 20% extra air, causing the cushion to feel like a hard bubble to sit on.Upon review of the order, the cushion was requested with a 20% equal overfill of the jay flow fluid in all chambers of the bladder.There has been no additional information on influential environmental conditions.A review of the product's dhr shows the j2 dc cushion was made to specification.The end user reportedly stopped using the jay j2 dc cushion in march and has been using a spare cushion during the warranty claim process.The end user reports an alleged pressure injury with internal bleeding.There was no information provided on the location or the stage of the pressure injury.The end user reports the treatment involves bedrest.There is no further information on the current severity of the pressure injury or if any additional medical action was necessary.Upon further discussion with the sunrise medical clinical team, the language "internal bleeding" is an indication of other factors (such as bleeding from internal organs) that are not likely related to pressure injuries.Conclusion: in conclusion, there is no clear indication of a product malfunction.This device is used for treatment, not diagnosis.Due to the allegations of a serious injury (pressure injury requiring bedrest), this mdr is being filed.

Event Description

In reviewing the complaint, the wheelchair repair technician reports that the "gel pad" in the cushion had 20% extra air, causing it cushion to feel like a hard bubble to sit on.The end user reports an alleged pressure injury with internal bleeding.The end user reports the treatment involves bedrest.There is no clear indication of a product malfunction.The end user is not currently using the cushion.

• Brand Name: JAY SEATING CUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL; 2842 n business park ave; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL; 2842 n business park ave; fresno CA 93727
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727
• MDR Report Key: 18252496
• MDR Text Key: 329552786
• Report Number: 9616084-2023-00067
• Device Sequence Number: 1
• Product Code: IMP
• UDI-Device Identifier: 00016958042504
• UDI-Public: 00016958042504
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: J2 DC CUSHION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2022
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 50 KG