MAUDE Adverse Event Report: SUNRISE MEDICAL TECHNOLOGIAS JAY CUSHION; JAY 2 DEEP CONTOUR CUSHION

Model Number JAY 2 DEEP CONTOUR

Device Problem Gas/Air Leak (2946)

Patient Problem Pressure Sores (2326)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Sunrise medical's customer service rep, manager and supervisor called (b)(6) (spouse of end user (b)(6)) on 1/17/19 to discuss the issue with the cushion.(b)(6) stated they received (b)(6)'s cushion on (b)(6) 2018 and she stated it appeared to be defective.Her husband (b)(6) got 2 pressure sores in (b)(6) and (b)(6) believes it is due to two pockets of air in the bladder.(b)(6) stated in the 30 years of using our product they never had this issue before ((b)(6) has 3 previous jay cushions).She claims (b)(6) was hospitalized 6-7 weeks after an infection went into his bone.He had 1,435 cubic centimeters of flesh removed.They purchased a hospital bed after the surgery.(b)(6) says she noticed the air pockets when she got into (b)(6)'s chair after the infection.They noticed redness in (b)(6) during their 6 week trip to (b)(6); by (b)(6) the bone was exposed and (b)(6) needed surgery.(b)(6) had surgery on (b)(6) 2018; due to the tissue damage, he had a colostomy.He was on antibiotics for 6 weeks and is currently waiting for flap surgery.Sunrise medical's supervisor, (b)(4), asked if a call tag could be sent so the cushion could be returned to our quality team to evaluate.(b)(6) stated she would not get rid of the cushion because she needs it for evidence purposes, as there is a medicare investigation occurring.(b)(4) advised (b)(6) that (b)(6) should not use his current cushion and wanted to get a replacement cushion out to (b)(6) asap.(b)(4) suggested to (b)(6) to please get with the dealer, (b)(4), asap so he can order the best cushion for (b)(6).This issue was discussed on 1/30/19 by sunrise medical's ra/qa and mdr team.Since the end user's wife (b)(6) refuses to return the cushion for a thorough inspection and evaluation, sunrise medical is unable to confirm the alleged deficiency.Further discussion in the meeting addressed that if the cushion in fact had air bubbles, it would not likely cause or contribute to the injuries the end user claims to have received.If there were any air bubbles they would simply be displaced when the end user sat on the cushion.This would still allow for the user to sit on fluid that fills the chambers of the cushion's fluid insert.It is likely that the alleged pressure sore that led to the infection was developed in the time leading up to and during the 6 week (b)(6) trip that (b)(6) says they took.An area of concern is that (b)(6) claims she and her husband noticed redness in (b)(6); however, it was not stated that the issue was addressed, and by (b)(6) hospitalization was required for (b)(6).Sunrise customer service manager, (b)(4) also received a call on 1/31/19 from dealer, (b)(4) with (b)(4).He expressed his extreme surprise because he was not made aware of this issue by the end user when the injury happened and that the injury was so severe by the time they ((b)(6) and (b)(6)) noticed.(b)(4) was not aware of this issue until early january 2019.This mdr is being filed to report the alleged injury; however, sunrise medical does not consider this issue to have been caused by a deficiency in the subject cushion.This is likely due to a pre-existing issue that was not addressed in a timely manner that ultimately led to the end user's hospitalization.(b)(4) is working with the end user on providing a replacement cushion.The end user did not provide his age, weight or height.This incident is also being addressed by sunrise medical's legal team.No further investigation will be performed by sunrise medical's ra/qa team at this time.

Event Description

Sunrise medical's account manager, (b)(4) reported that he and dealer, (b)(4), made a visit to the patient's home.The visit was to look at the end user, (b)(6)'s, jay 2 deep contour cushion that he and his wife claim has a significant air bubble in the bladder of the cushion.They allege that is the cause of a pressure sore that has racked up over (b)(6) in medical costs for a decubitus ulcer, skin flap surgery and all the associated costs.

• Brand Name: JAY CUSHION
• Type of Device: JAY 2 DEEP CONTOUR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL TECHNOLOGIAS; no. 110 parque industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 8337696
• MDR Text Key: 136117545
• Report Number: 9616084-2019-00002
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY 2 DEEP CONTOUR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2018
• 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): Hospitalization; Required Intervention