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

Model Number	M3
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user's mother reported while out camping at night, the end-user was driving over a non-paved area where it was alleged the headlights of the device went out.The end-user continued to drive at an undescribed speed, and reportedly hit a pothole.This caused the device to lose stability and fall over on to its right side.The mother reported the end-user was taken to the hospital but was not forthcoming as to the extent of injury or if any serious injury was incurred.Reports indicate the client is currently home with no information if remedial medical follow-up is required.Service provider reported having inspected the device and found it to be fully functional with no notable operational issues.Inspection of the headlights and taillights for the device were found fully operational upon their inspection and could not find any loose connections or damages to which the alleged failure could be attributed.Service provider believes the reported event was the result of inadvertent use error as no mechanical or electrical issues were found.The dhr was reviewed and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report stating as the end-user was driving the wheelchair out-of-doors at night, the headlights on the wheelchair stopped functioning which caused the end-user to lose vision of the terrain where they inadvertently maneuvered the device into a pothole causing the device to lose stability and fall over onto its side.Report claims the end-user was taken to the hospital for treatment for undescriptive injuries.

• Brand Name: PERMOBIL M3
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 12299854
• Report Number: 1221084-2021-00026
• Device Sequence Number: 3532429
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• 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): 08/10/2021

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: 07/13/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization