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

Model Number J2

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 6 months.The expected lifetime of a wheelchair cushion is 2 years.Discussion: in reviewing the complaint, the user reports that the gel pack is leaking.Due to lack of any additional information, we cannot determine whether the failure mode should be classified as a manufacturing malfunction or as a failure due to end-user misuse.No injury is reported.Conclusion: due to previous filings for what could be a similar failure mode of manufacturing malfunction, which could lead to a serious medical condition if any such malfunction were to recur, this mdr is being filed in an abundance of caution.Additional note: due to employee absences this file as overlooked and filed late.Corrective actions have been put in place to address these types of late notifications to the regulatory department.

Event Description

Dealer states that the gel pack "is leaking." no injury described.

• 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 (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 13688760
• MDR Text Key: 291720840
• Report Number: 9616084-2022-00004
• 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: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: J2
• Device Catalogue Number: J2
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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 Weight: 125 KG