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.
|