MAUDE Adverse Event Report: PERMOBIL INC PERMOBIL M CORPUS VS; POWERED WHEELCHAIR

Model Number	M VS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports indicate the retractable panel holder for the joystick was positioned in a fashion to where if it were rotated inwards, the inductive of the joystick could come into contact with the bracketry of the tray, if installed.At one point, while the device was powered on, the end-user inadvertently pivoted the joystick inwards, making contact with the tray hardware, which caused the device to turn rapidly to the right forcing the device to impact the wall.The ensuing impact reportedly resulted in a fracture to the end-user's right ankle.The local service provider inspected the device finding no mechanical malfunctions having occurred and re-adjusted the panel holder into a position to where contact would no longer be made if joystick was rotated inwards in the future.A review of the device history record from the date the device was manufactured was performed which noted that this device was not involved in manufacturing quality non-conformance.
Event or Problem Description
Received report claiming the retractable panel holder, when rotated inwards, would allow the joystick to contact the tray mounting hardware and this would engage an involuntary drive command.Reports on one instance, the chair was inadvertently driven into a wall where the end-user sustained a fracture to their ankle.

• Brand Name: PERMOBIL M CORPUS VS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 24757557
• Report Number: 1221084-2026-00004
• Device Sequence Number: 9092045
• Product Code: IPL
• UDI-Device Identifier: 17330818002003
• UDI-Public: (01)17330818002003(11)250904
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: M VS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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: Other
• Patient Sex: Unknown