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U.S. Department of Health and Human Services

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

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SUNRISE MEDICAL (US) LLC JAY SEATING CUSHION; WHEELCHAIR CUSHION Back to Search Results
Model Number JAY FUSION 17X19
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Dealer states that the fluid bladder leaked at the seam onto base foam.No injury described.
 
Manufacturer Narrative
Background information: the age of the cushion at the time of the complaint was 1 year, 8 months.The expected lifetime of a wheelchair cushion is 2 years.Discussion: in reviewing the complaint, the user reports that the fluid bladder has allegedly leaked at the seam on the foam base.The cushion is within its expected lifetime and seam splits are considered, by the manufacturer, to be a manufacturing defect.Therefore, this is classified as a malfunction.There are no injuries reported.Conclusion: due to previous filings for serious injuries related to similar failure modes, which could lead to a serious medical condition if any such malfunction were to recur, this mdr is being filed out of an abundance of caution.
 
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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 Key13826833
MDR Text Key290794038
Report Number9616084-2022-00010
Device Sequence Number1
Product Code IMP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberJAY FUSION 17X19
Device Catalogue NumberJAY
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/02/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Weight82 KG
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