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

Model Number JAY FUSHION

Device Problem Degraded (1153)

Patient Problem Pressure Sores (2326)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

Background information: with standard wear and tear of cushions, this is considered a malfunction only if the product wears out prior to the standard lifetime of 2 years.When seat cushions malfunction, there is a potential for contributing to serious injuries in the forms of pressure sores (open wounds) that, if left medically untreated, can lead to catastrophic medical events.Therefore, out of an abundance of caution, pressure sores (regardless of the severity of injury suffered in a specific incident) are reportable events.Sunrise products that are ordered with cushions, are provided cushions per dealer/provider specifications.There are numerous cushion configurations; some are designed for individuals more prone to developing pressure sores and some are not.The determination of whether or which cushion is needed is the dealer/provider responsibility to specify as some users may be determined, by a mobility specialist, to need specific cushion types (fluid, gel, foam, etc.).This requirement cannot be determined by sunrise medical as we do not know the condition of the end user, nor the specific needs of their disability.When specific cushions are provided, per dealer requirements, the expectation is the cushion will be free of manufacturing defects and will perform in accordance with all written materials (website, owner manual, etc.).When cushions do not perform as intended, it is considered a malfunction of the device and pressure sores, whether a serious injury or not, have the potential for becoming a serious injury.Therefore, all malfunctions of wheelchair cushions are considered reportable events.Discussion: the cushion at the time of the complaint was 1 year 10 months of age.The lifetime of a wheelchair cushion is 2 years.Therefore, this cushion had not yet reached its effective lifetime and is a malfunction, likely, of manufacturing.Conclusion: due to the malfunction of the cushion and an injury with the potential for developing into a serious injury, an mdr is being filed.Additional information: this complaint has been re-reviewed as a part of a four-year retrospective review and remediation effort based on enhancements made to the company's complaint handling and adverse event reporting processes.A legal consulting firm was consulted for the retrospective review.This mdr is being filed based on the outcome of that retrospective review.

Event Description

Jay fusion cushion was reported to be leaking (gel pad) and foam was "flat." this contributed to pressure sore (level 1) "beginning to develop." the end user discontinued use of the cushion, therefore, did not progress to a serious injury.However, were the malfunction to recur, it could lead to serious injury.

• Brand Name: JAY FUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, CA 93702-1328
• MDR Report Key: 12318769
• MDR Text Key: 266459382
• Report Number: 9616084-2021-00042
• Device Sequence Number: 1
• Product Code: KNN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY FUSHION
• Device Catalogue Number: JAY
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• 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 Outcome(s): Other
• Patient Age: 15 YR
• Patient Weight: 84