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

Model Number	JAY UNION
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Background information: 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 current complaint mentions that the gel packet inside the jay union cushion detached from the foam base and then rolled into a ball creating a pressure point under the user's buttock.He reported that he developed a pressure sore, but also stated it was not an injury.Therefore, the presumption is that it was an early stage (level 1) pressure sore that did not break the skin.However, left untreated this type of injury can progress to a serious injury.Conclusion: due to the malfunction of the cushion and an injury with the potential for developing into a serious injury, this 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 or Problem Description
Dealer stated that the gel packet came unglued from the base and rolled into a ball causing a pressure point on the end user's buttock.Skin was not broken, this was not a serious injury.However, left untreated, it has the likelihood of progressing to a serious injury; therefore, mdr is being filed.

• Brand Name: JAY UNION
• Common Device Name: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• MDR Report Key: 12318604
• Report Number: 9616084-2021-00041
• Device Sequence Number: 19862357
• Product Code: IMP
• UDI-Device Identifier: 00016958056402
• UDI-Public: 00016958056402
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: JAY UNION
• Device Catalogue Number: JAY
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other