MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M300; POWER WHEELCHAIR

Model Number	M300
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Collision (1429); Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports the injury sustained was caused by the swing away panel holder being broken to the point to where it could no longer be tightened to stay in position, reportedly causing the jsm to swing inwards towards the end-user.When this occurred, the end-users stomach engaged the jsm causing the device to rapidly turn to the right.Reports indicate the end-users right foot contacted an immovable object causing their foot to twist which resulted in a distal radial fracture to their right fibula.Va records indicate the device had been assessed approximately 1 month prior and a replacement panel holder had been ordered and shipped to facility to install.The va does not have any record of the panel holder having been replaced prior to the event.Reports provided to permobil indicate the cause of the panel holder to become compromised was due to over tightening in attempts to completely immobilize the joystick from movement.In efforts to keep this from recurring, a parts order was placed for a "fixed" panel holder which will immobilize the joystick from any lateral movement.The dhr was reviewed and device met specification prior to distribution.
Event or Problem Description
Received report claiming end-user inadvertently rotated the swing away joystick inwards towards his body.When this occurred, the end-users stomach engaged the joystick causing the device to rapidly turn to the right.Reports indicate the end-users right foot contacted an immovable object causing their foot to twist which resulted in a fracture to their right fibula.

• Brand Name: PERMOBIL M300
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke dr.; lebanon TN 37090
• MDR Report Key: 9350522
• Report Number: 1221084-2019-00051
• Device Sequence Number: 2812440
• Product Code: ITI
• UDI-Device Identifier: 17330818123401
• UDI-Public: 17330818123401
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

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: M300
• 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: 11/08/2019
• Initial Report FDA Received Date: 11/20/2019
• 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
• Patient Weight: 129