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

Model Number JAY J2 CUSHION

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.Discussion: in reviewing the complaint, the fluid pack is leaking from the rear seal.Due to lack of any additional information, there is no indication based on the information provided whether the event was due to a product malfunction or damage due to potential user misuse.No injury is reported.Conclusion: due to previous filings for serious injuries possibly related to similar failure modes, which could become a serious medical condition if any malfunction were to recur, this mdr is being filed out of an abundance of caution.

Event Description

Dealer reports the fluid pad is leaking from the rear seal.No injury described.

• Brand Name: JAY SEATING CUSHION
• Type of Device: 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: 13744428
• MDR Text Key: 291720161
• Report Number: 9616084-2022-00008
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JAY J2 CUSHION
• Device Catalogue Number: JAY
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 59 KG