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

Model Number	M5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Reports while end-user was traversing through their home from great room to bedroom, the footplates reportedly contacted a threshold which caused the device to stop suddenly.This forced the end-user to lose positioning and fall from the seating which resulted in an injury requiring medical intervention to address.
Additional Manufacturer Narrative
Reports indicate the end-user was traversing through their home and claims the footrest/leg tube had contacted a threshold rise.This contact reportedly caused the device to stop suddenly which forced the end-user, who was not wearing a positioning belt, to lose positioning and slide out of the seating to the ground.The fall resulted in a fracture to the left femur.The end-user is described as approx.240lbs in weight, @ 6'2" in height.The device was originally configured for 18.5" seat to floor, w/16" lower leg length, and 20° anterior tilt.The va therapist reported to permobil representative knowing of the end-user's longer lower leg length and commented on how he had instructed the end-user to position his seating accordingly (tilt) to ensure clearance was available for the footplates during situations like these.No claims or allegations were made of a product malfunction having occurred to have contributed to this event.The end-user is being re-evaluated for a new device to meet their current seating requirements.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• 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: 17599027
• Report Number: 1221084-2023-00014
• Device Sequence Number: 6712787
• Product Code: ITI
• UDI-Device Identifier: 17330818334562
• UDI-Public: 17330818334562
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 08/22/2023

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: 07/25/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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