MAUDE Adverse Event Report: SUNRISE MEDICAL TECHNOLOGIAS JAY BACK; JAY BASIC BACK

Model Number JAY BASIC BACK

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 01/12/2019

Event Type  Injury  

Manufacturer Narrative

The jay basic back was installed on a competitor's 20" lightweight drive cruiser chair.The dealer stated the metal brackets on the jay basic back are bent and threading is worn down.She states that one is still attached to chair, but there are missing parts on the back.The dealer returned the jay basic back to sunrise medical and it was received on 1/30/2019.The back was inspected and evaluated by quality manager, (b)(4), that same day.The following are findings from that evaluation: evaluation: the inspection confirms that components are missing as not all parts, such as clamps and brackets were not returned.The brackets show excessive wearing of the coating.The holes where the mounting screws fasten to, are stripped.Sunrise medical manufacturing does not adjust these screws in order to allow dealers to position the back on the chair and make adjustments as needed.The remaining screws that are on the back are overtightened.The torque is greater than the recommended torque specification of 15-20 in-lbs., as stated on page 6, section c of the jay basic back owner's manual.The upper brackets are incorrectly twisted downward in their assembly.This can cause stress in the receiver.These brackets are width adjustable and would have been adjusted by the user/dealer when the back was mounted onto the chair.Conclusion: based on the findings from the evaluation, sunrise medical has concluded that the failure was due to incorrect installation of the back by the dealer or the end user.There was no malfunction or defect found.This issue/incident is under further investigation by sunrise medical's legal team as the dealer has advised that the end user has sought legal counsel for this incident.No further investigation will be performed by sunrise medical's ra/qa team at this time.

Event Description

Per the dealer, (b)(4), daughter of patient was transferring patient from shower to chair when back came loose and patient fell and broke hip.(b)(4) states the end user was discharged from hospital on (b)(6).

• Brand Name: JAY BACK
• Type of Device: JAY BASIC BACK
• 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: 8337805
• MDR Text Key: 136114974
• Report Number: 9616084-2019-00003
• 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 BASIC BACK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention