MAUDE Adverse Event Report: INVACARE CORPORATION DBA INVACARE AMERICA INVACARE STORM TORQUE RX POWER WHEELCHAIR; POWERED WHEELCHAIR

Model Number	SRX-20MP
Medical Device Problem Codes	Unintended Collision (1429); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject wheelchair, a three-year-old storm rx, consists of a base that was manufactured by invacare.The base was sent to motion concepts for the seating components.Multiple attempts were made to obtain additional information including the terrain type, the degree of incline, the conditions at the time of the incident, clarification on the veering and whether it was due to any external sources including the presence of dog alongside of the user.No further information or responses were received.Without this additional information, the underlying cause of this incident cannot be determined, and a device malfunction is not confirmed.It was noted that with the information provided, the seat positioning strap was not in use at the time of incident.The invacare user manual includes instructions and warning regarding the use of the seat positioning strap to reduce the risk of falls.The manual also provides warnings about the use of the device on inclines/grades.The power wheelchair base user manual advises of a risk of death or serious injury: not wearing your seat positioning strap could result in death or serious injury.Always wear your seat positioning strap.The seat positioning strap helps reduce the possibility of a fall from the wheelchair.Additionally, the manual advises loss of traction or stability on inclines/grades or ramps may cause injury, damage or death.Surfaces that may be wet, icy, oily, slippery, painted, treated wood, rotten wood, rusted metal or other similar surfaces or materials may also increase risk.Do not use on inclines or ramps where surface is uncertain or compromised.Do not use on inclines greater than nine (9) degrees.At this time no further information is expected.Replacement components were provided to the dealer for repair of the wheelchair.A return is not anticipated.If additional information is received, a follow-up will be filed.
Event or Problem Description
On january 21, 2026, a (b)(6) representative advised the dealer had reported to them that when an end-user was operating the wheelchair on a downhill slope with her dog alongside, the unit veered uncontrollably to the left.The wheelchair subsequently collided with a curb resulting in the end-user being thrown from the wheelchair.The end-user sustained a femur fracture requiring surgical intervention performed on (b)(6) 2026.

• Brand Name: INVACARE STORM TORQUE RX POWER WHEELCHAIR
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): INVACARE CORPORATION DBA INVACARE AMERICA; one invacare way; elyria OH 44035
• Manufacturer (Section G): INVACARE CORPORATION DBA INVACARE AMERICA; one invacare way; elyria OH 44035
• Manufacturer Contact: dona bhamra ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 24387133
• Report Number: 1531186-2026-00001
• Device Sequence Number: 10518264
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: SRX-20MP
• Device Catalogue Number: SRX-20MP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• 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: 95 KG