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

Model Number JAY SYNCRA PAD

Device Problem Burst Container or Vessel (1074)

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

Event Type  malfunction  

Event Description

Dealer called in stating the end user's cryo fluid pad popped at the seams causing the fluid to leak out.No injuries were reported.

Manufacturer Narrative

Background information: the age of the cushion at the time of the complaint was 1 year and 7 months.The expected lifetime of a wheelchair cushion is 2 years.Discussion: in reviewing the complaint, there is no indication based on the information provided whether the event was due to a product malfunction during normal use or damage due to potential user misuse.The user reported no injuries.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.

• 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: 13725710
• MDR Text Key: 290794247
• Report Number: 9616084-2022-00007
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JAY SYNCRA PAD
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• 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: 109 KG