MAUDE Adverse Event Report: INVACARE TAYLOR ST. AVIVA STORM RX; POWERED WHEELCHAIR

Model Number	NA:SRX-20MP
Medical Device Problem Codes	Break (1069); Device Tipped Over (2589); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Head Injury (1879); Laceration(s) (1946); Pain (1994); Swelling/ Edema (4577)
Date of Event	06/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
While using the aviva rx powerchair on a flat surface, the end user turned approx.30 degrees to access a curb cutout to maneuver from the street to the sidewalk.The left front wheel and caster components came off the chair entirely.This resulted in the chair to tip and fall to the left.The end user landed face first on the pavement breaking the chairs armrest with left side of her body.The end user sustained a bump on her forehead, broken glasses lacerating the bridge of her nose and her jaw being scraped.The end users face had multiple cuts, swelling and bruising.Her left hand was suspected of fracture, so she was taken to the hospital for evaluation.A ct scan of head/neck was clear, and x-rays of her hand showed no breaks.There was a bump on her left hand and continuous pain, limiting use of her hand at the time of communicating the incident.
Additional Manufacturer Narrative
This issue is related to a 1-year-old srx-20mp (aviva rx) power wheelchair.The powered base of this device was manufactured by invacare.Motion concepts installed the seating system.Motion concepts confirmed that they provided their caster/fork replacement kit to the dealer on 1/28/2025, related to a previous caster issue.After evaluation of the information and picture made available, motion concepts stated this appears to be related to an installation error by the dealer.Motion concepts is to address this error with the dealer.Motion concepts also confirmed that all the seating systems they sell have the postural belt installed.They confirmed with the dealer that the end user was not wearing a postural belt at the time of the incident.Also, it was noted that one side of the wheelchair would need to be lifted by 5 inches or more for the casters to detach from the system.It is unknown what may have contributed to the chair being off the ground far enough for the caster to detach with the information available.Motion concepts is working with the dealer and end user for a solution.At the time of this report the end user will not release the chair and does not want another system due to the traumatic event.No return of the device is expected at this time.If additional information becomes available, a supplemental record will be sent accordingly.The owner's manual for the aviva rx includes the following: not wearing your seat positioning strap could result in death or serious injury.Always wear your seat positioning strap.Your seat positioning strap helps reduce the possibility of a fall from the wheelchair.If signs of wear appear, seat positioning strap must be replaced immediately.

• Brand Name: AVIVA STORM RX
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 22978551
• Report Number: 1525712-2025-00011
• Device Sequence Number: 15840127
• Product Code: ITI
• UDI-Device Identifier: 00841447114581
• UDI-Public: 00841447114581
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: NA:SRX-20MP
• Device Catalogue Number: SRX-20MP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 79 KG