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

Model Number JAY 2 DEEP CONTOUR CUSHION

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pressure Sores (2326)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Background information: jay j2 deep contour cushion owner manual, page 2, states, "check sitting pressure often.Your jay cushion was designed for sitting comfort and postural support.Users should inspect their skin daily for redness.The clinical indicator of tissue breakdown is skin redness.If your skin develops redness, discontinue the use of the cushion immediately and see your doctor or therapist." jay j2 deep contour cushion owner manual, page 2, states, "warning! your jay cushion is designed to help reduce pressure.However, no cushion can completely eliminate sitting pressure or prevent pressure sores.The jay cushion is not a substitute for good skincare including, proper diet, cleanliness, and regular pressure relief." jay j2 deep contour cushion owner manual, page 5, states, "note: when the cover is removed from the cushion for cleaning inspect the fluid pad and foam base for unusual wear.Feel the fluid for any inconsistencies.If inconsistencies are found, knead the fluid pad to original consistency and/or call jay customer service at sunrise medical." pressure sores (open wounds), if left medically untreated, can lead to serious injury.Therefore, out of an abundance of caution, sunrise medical typically considers pressure sores reportable events.Discussion: the age of the cushion at the time of the complaint was 13 months.The expected lifetime of a wheelchair cushion is 2 years.In reviewing the complaint, the end user reports that the fluid pad in the cushion was "pretty hard".Fluid cushions can develop hard spots if not properly maintained.According to the j2 contour cushions owner's manual, fluid pads should be kneaded to original consistency when inconsistencies are found.It is possible the end user was not following maintenance instructions, which could be found to be the root cause for the malfunction.The end user also reported that due to his bed breaking, he had been using his wheelchair as a bed.Prolonged sitting and lack of pressure relief can potentially lead to pressure sores.According to the end user, he believes that using his chair in this manner had allegedly led him to develop the reported pressure sores.The end user is currently receiving treatment at a medical rehab center for the latter two pressure sores reported.There is limited information about the treatment and severity on the initial pressure sore that was reported to occur 10 months ago, only that the pressure sore had trouble healing and that allegedly, "the sore almost reached the bone." there is no further information regarding progress of current treatment and whether any follow up will be required.Conclusion: due to previous filings for serious injuries possibly related to similar failure modes and the related allegation of pressure sores, which could become a serious medical condition if any malfunction were to recur, this mdr is being filed.

Event Description

End user reported that the fluid pack in the cushion was hard and that due to his bed breaking, he had been using his wheelchair to sleep in.The patient reports that these factors allegedly lead to him developing multiple pressure sores, one 10 months ago on his right leg by the buttocks, and two more recently on his leg and back.He states that he is currently receiving treatment at a medical rehab for the latter two pressure sores.

• 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: 14310840
• MDR Text Key: 290965397
• Report Number: 9616084-2022-00011
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JAY 2 DEEP CONTOUR CUSHION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• 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 Outcome(s): Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 69 KG