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

Model Number	M300
Medical Device Problem Codes	Mechanical Problem (1384); Vibration (1674); Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user contacted permobil as a general inquiry regarding service activity on their device and their belief the service provider is not able to repair correctly.In their report, the end-user made mention of having suffered an injury after having lost control of their device while traversing down a ramp.It was described as while they were descending the ramp at speed, the front caster wheels started to shake which caused the end-user to lose control of the joystick control allowing them to lose positioning and fall out of the seating to the ground.The ensuing fall was reported to have resulted in the end-user suffering a fracture to their 5th phalange (pinky) on the left hand.Review of device history indicates the service provider having contacted permobil to order parts in the timeframe the end-user reported this event having occurred, (b)(6) 2019, but there was no record of an injury being reported.As this reported event had occurred over a year ago and various components have been replaced during that time span, permobil cannot confirm a device malfunction had occurred as none of the components replaced were returned to permobil for evaluation of potential product failure.The dhr was reviewed and the device was found to have met specification prior to distribution.
Event or Problem Description
End-user reports as they were transitioning down a ramp, they reportedly lost control of the device which caused them to lose positioning and fall out of the seating.The resulting fall was reported to have caused an injury requiring medical intervention.

• Brand Name: PERMOBIL M300
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke dr.; lebanon, tn
• MDR Report Key: 10264789
• Report Number: 1221084-2020-00031
• Device Sequence Number: 11349193
• Product Code: ITI
• UDI-Device Identifier: 17330818123401
• UDI-Public: 17330818123401
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/13/2020
• 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; Required Intervention
• Patient Weight: 113