MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M5; POWERED WHEELCHAIR

Model Number	M5
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	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following the reported event, the device was inspected by permobil representative and service provider.Reports indicate the device was found to remain fully operational with no notable deviations during drive.It was however noted by the end-user's physical therapist of the end-user's response time with the drive controls at their current settings as being slower than what the device had been previously programmed for.Reports indicate adjustments were made to various drive parameters to better meet the end-user's current needs.Operational testing with the end-user was performed with reports of the end-user having better control of the device.Permobil was unable to confirm a product malfunction having occurred as described, and is unable to reach a determination as to probable root cause for the event without speculation.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Report received claiming as the end-user was exiting a transport vehicle via the incorporated ramp, the wheelchair allegedly veered to the right, allowing one of the caster wheels to fall off the ramp causing the device to lose upright stability and fall on to its side.This action caused the end-user to fall out of the chairs seating where they sustained an injury requiring medical intervention to address.

• Brand Name: PERMOBIL M5
• 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: 20846574
• Report Number: 1221084-2024-00024
• Device Sequence Number: 15478911
• Product Code: ITI
• UDI-Device Identifier: 17330818334562
• UDI-Public: 17330818334562
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/04/2024

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: M5
• 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: 11/18/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2023
• 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