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

Model Number	M3
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report claiming as the end-user was in process of exiting their transport vehicle via installed ramp, the end-user reported having let go of the joystick control and the device continued to roll, at an angle, forcing the device to roll off the side of the ramp.The ensuing fall resulted in an injury requiring medical intervention.
Additional Manufacturer Narrative
Device was inspected by permobil representatives who reported where the event occurred was during the transition from leaving the motor vehicle and making the transition to the ramp.It was reported to line the device up to where it was square to the ramp, many small turns inside the vehicle were required.It was reported that when the end-user was making the initial transition down the ramp, as soon as the rear wheels made the transition, the rear of the device made a slight shift to the right, and when letting go of the joystick the device continued to roll for a bit which allowed the rear wheels to drop off the edge of the ramp, forcing the device to lose upright stability and fall off the side.This fall resulted in the end-user sustaining bi-lateral fractures to their tibias requiring medical intervention to address.Permobil was unable to find any mechanical or operational abnormalities with the device.Testing confirmed the device continuing to roll slightly when bringing the joystick to the neutral position, but not to where the device rolled to the ramps edge when device was properly centered on the ramp surface.This reported roll was determined to be normal as the motors decelerate before the electric brakes engage.The device could roll father while on a decline, due to gravitational pulls, before the brakes engage.It was noted this anomaly only occurred when device was in transition from flat surface to a decline and did not have any issues of veering or excessive rolling on level surfaces.As no product malfunction was found, permobil is unable to determine a root cause without speculation.The dhr was reviewed, and device was found to have met specification prior to distribution.

• 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: 15281709
• Report Number: 1221084-2022-00015
• Device Sequence Number: 7166357
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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: 07/26/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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