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

Model Number	M3
Medical Device Problem Codes	Mechanical Problem (1384); Device Tipped Over (2589); Unintended Movement (3026)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	06/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil received call from reporter who identified themselves as counsel for the end-user to report an incident having occurred on (b)(6) 2023 where the device reportedly fell over forward and landing atop the end-user.The reporter described the event as the end-user traversing down a described "very steep" walkway that was incorporated to allow access to a local restaurant.The reporter described this pathway to appear extremely steep to where even able-bodied individuals would give second thought to use.It was described that approximately halfway down the device reportedly tipped over forward, due to the extreme grade, and landed atop the end-user which resulted in an fx to the femur, and undescribed injuries to their face and head.The reporter stated they are not making any claim or allegation of the device having malfunctioned in any way to have contributed to this event, with reports of the device remaining fully operational both before and after the reported event.Permobil provided reporter a copy of the user manual which outlines maximum recommended angles for safe operation.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Reports while traversing down a steep grade pathway, the device reportedly tipped over forward, landing atop the end-user which resulted in serious injury.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: 20244827
• Report Number: 1221084-2024-00018
• Device Sequence Number: 7301636
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: 08/29/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2024
• 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