MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M3; POWERED WHEELCHAIR

Model Number	M3
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Multiple Fractures (4519)
Date of Event	05/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user described the sequence of events as being in process of exiting a transport vehicle via an incorporated ramp, driving the device via a joystick controller.End-user reports during the transition, the device unexpectedly accelerated and before they could respond, the device drove off the side of the ramp resulting with the device landing atop the end-user on the ground.Reports indicate the end-user sustained multiple fractures to both left and right legs, ankles, and feet which required medical intervention within a hospital setting.The device was inspected and evaluated by permobil representatives in conjunction with the local service provider.Finding reports indicate the device remains fully functional with no signs of a device malfunction having occurred that may have contributed to the event.The allegation of "involuntary acceleration" was unable to be confirmed or replicated through testing, leaving permobil unable to determined possible root cause of event without speculation.After inspection was completed, the device was returned back to the end-user with no reports of recurring issues being received.The dcr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming while the end-user was exiting van via a ramp, the device reportedly accelerated which caused the end-user to lose control and drive off the side of the ramp, falling to the ground.This resulted in injuries to the end-user requiring medical intervention to address.

• Brand Name: PERMOBIL M3
• 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: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 19550242
• Report Number: 1221084-2024-00010
• Device Sequence Number: 20046548
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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: M3
• 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: 05/23/2024
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Prefer Not To Disclose